Correlation between Nutritional Intake and Body Composition in Adolescents with Thalassemia Major

doi:10.21203/rs.3.rs-4943551/v1

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Research Article

Correlation between Nutritional Intake and Body Composition in Adolescents with Thalassemia Major

https://doi.org/10.21203/rs.3.rs-4943551/v1

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Background: Growth failure is common in thalassemia major (TM) patients. Measurement of lean body mass, fat mass, and bone mass density (BMD) are important components in assessing the body composition and nutritional status of TM patients. There are no previous studies in Indonesia that have evaluated the correlation between macronutrient or micronutrient intake and body composition in adolescents with TM.

Methods: This study included 55 subjects with TM aged 10-18 years old at the Thalassemia Center of Dr. Cipto Mangunkusumo National Hospital Jakarta. Macronutrient and micronutrient intake were evaluated using a three-day food record. Fat mass, lean mass, and bone mineral density (BMD) were assessed using dual-energy X-ray absorptiometry (DXA). Vitamin D levels were evaluated using enzyme-linked immunosorbent assay (ELISA) method. The data was analyzed with Pearson and Spearman correlations, depending on the type of distribution.

Results: Energy intake was significantly associated with muscle mass, fat mass, and BMD (r = 0.35, 0.39, and 0.27 respectively, p-value <0.05). There was a significant correlation between protein intake on muscle mass, fat mass, and BMD (r = 0.60, 0.37, and 0.31 respectively, p-value <0.05). There was a mild correlation between energy intake and fat mass percentage in male and female subjects (r= 0,25, p= 0,017; r= 0,38, p= 0,02). There was no correlation between carbohydrate, fat, and protein, vitamin D, vitamin E, calcium, and folic acid on the proportion of muscle mass percentage, fat mass percentage, and BMD.

Conclusion: More than half of adolescent TM patients are malnourished and lack protein intake. Body composition correlates with total calorie intake.

nutritional intake

nutritional status

calorie intake

body composition

thalassemia major

Thalassemia major (TM), commonly known as Transfusion Dependent Thalassemia (TDT), is a severe type of thalassemia characterized by low hemoglobin levels so that the patient needs blood transfusion for life.¹ Although blood transfusion optimization and iron chelation therapy have increased the patient’s life expectancy, a complication might happen. Growth failure is one of the most frequently reported complications in children and adolescents with thalassemia major.² The growth deficit ranges from 20–65%, according to the severity of the disease.

Growth disorders in thalassemia can be caused by many factors, such as chronic hypoxic conditions due to chronic anemia, hepatic iron overload with liver dysfunction, and iron-related endocrinopathy.³ Furthermore, TM patients have a risk of macronutrient and micronutrient deficiencies. An imbalance between nutritional needs and intake that results in a cumulative deficit of energy, protein, or micronutrients can have an undesirable effect on the growth and development of thalassemic children.⁴ Nutritional treatment is one of the essential aspects of optimizing thalassemic patient clinical outcomes. The guidelines from the Thalassemia International Federation (TIF) generally emphasize the importance of providing adequate and balanced intake and the need for periodic nutritional assessments and consultations following pediatric nutrition care.⁵ TM patients require high calorie and protein intake and adequate fat intake. They also need sufficient micronutrient intake, but unfortunately, the recommended micronutrient intake in adolescents with TM is still limited. The National Guidelines for Medical Services on the management of thalassemia in Indonesia only recommend supplementing vitamin E and folic acid in TM patients, while vitamin D and calcium supplementation are still in the planning stage of recommendation.⁶

Nutritional monitoring and adequate intervention are needed by TM patients as a modality in long-term treatment to prevent nutritional disorders, growth disorders, pubertal development disorders, and immune deficiencies.⁷ The success of nutritional management can be evaluated based on the body composition assessment by various methods. A simple procedure for assessing body composition can use anthropometric measurements of body weight based on height, body mass index (BMI), mid-upper arm circumference (MUAC), triceps skin thickness (TSK), and mid-upper arm muscle circumference (MUAMC). The body composition measurement can be assessed through a dual-energy x-ray absorptiometry (DXA), which is the gold standard for evaluating the percentage of muscle mass, fat mass, and bone mass density (BMD). The body composition is influenced by many factors, including age, gender, endocrine system status, nutrition, and exercise. In adolescents with TM, all of the above parameters are disturbed to impact body composition changes, which is reflected in fat store changes as measured by the percentage of fat mass, muscle mass, and BMD changes.⁸

Body composition monitoring during adolescence is essential because many aspects of body composition during this period predict future body composition in adulthood, including risk factors for various metabolic diseases, such as cardiovascular disease, diabetes mellitus, and osteoporosis.⁹ However, the studies on thalassemia body composition assessment in adolescents and its correlation with macronutrient and micronutrient intakes are still limited in Indonesia. Therefore, the appropriate body composition assessment method is expected to provide information on specific, adequate, and personalized nutritional interventions according to the needs of adolescents with TM.

This research is a cross-sectional analytical study design. The research was conducted at the dr. Cipto Mangunkusumo National Hospital Jakarta thalassemia clinic from March 2021 - April 2022. The research sample was adolescent TM patients aged 10–18 years who came for control at the dr. Cipto Mangunkusumo National Hospital Jakarta thalassemia clinic then met the inclusion and exclusion criteria and were taken consecutively until the minimum sample size was met.

Nutritional status and simple anthropometric examinations such as MUAC, TSK, and MUAMC were used to evaluate the patients. Patients were assessed for dietary analysis to determine nutritional intake using the food record technique for three days conducted by a nutritionist. The results of the interviews were recorded in the Nutrition History form, then processed using the NutriSurvey for Windows 2003 program. It obtained absolute amounts of carbohydrate, fat, and protein intake (g), intake of vitamin D, vitamin E, calcium, and folic acid in total amounts (mcg), and the percentage compared to the Recommended Dietary Allowance (RDA). The patients' blood samples were taken to assess vitamin D, pretransfusion hemoglobin, serum ferritin, and calcium levels. Vitamin D and calcium levels were checked in the dr. Cipto Mangunkusumo National Hospital Jakarta laboratory. The mean pre-transfusion Hb and serum ferritin levels were calculated in the last one year. The patient's body composition was studied using a DXA device at the radiology department of dr. Cipto Mangunkusumo National Hospital Jakarta. Radiology department of dr. Cipto Mangunkusumo National Hospital Jakarta Kencana uses a DXA tool from the manufacturer GE Medical Systems Lunar to obtain the percentage of muscle mass, fat mass, and z BMD.

The research data will be processed with SPSS 25 as numeric and categorical data. For numerical data, a normality test was performed using the Kolmogorov-Smirnov test. In addition, Pearson correlation analysis was used on data with normal distribution. Meanwhile, the Spearman correlation test was performed for the abnormal distribution data.

The demographic characteristics of the subjects can be seen in Table 1. Of the 55 subjects, the proportion of gender is almost equal. A total of 58.2% of the subjects had short stature. Subjects who experienced late puberty were 16 (29.1%) patients aged 13–18 years. The mean pre-transfusion Hb level per year was below the recommended minimum pre-transfusion hemoglobin level target of 9 g/dL, with a high mean annual serum ferritin level of 6440.9 ng/mL. The examination results of vitamin D levels showed a deficiency in 11 (20%) subjects, insufficiency, and sufficiency in each 22 (40%) subjects. The mean vitamin D level was 16.9 (SD 5.68) ng/mL. The results of the calcium ion examination showed an average of 1.1 (SD 0.06) nmol/L. Most of the subjects had normal calcium values, and only one subject had hypocalcemia.

Table 1

Characteristics of Thalassemia Major Patients Who Took Part in the Study
Subject Characteristics	n (%)	Mean (SD)
Gender
Male	26 (47,3)
Female	29 (52,7)
Puberty
Delayed	16 (29,1)
Normal	39 (70,9)
Diagnosis
Homozygous β-Talasemia	42 (76,4)
β-Talasemia /HbE	12 (21,8)
Another TM (-α)	1 (1,8)
Nutritional status based on MUAC/age
Optimal nutrition	18 (32,7)
Moderate malnutrition	32 (58,2)
Severe malnutrition	5 (9,1)
Nutritional status based on weight/height
Optimal nutrition	42 (76,4)
Moderate malnutrition	13 (23,6)
Stature
Normal	23 (41,8)
Short stature	32 (58,2)
Mean Hb in the last one year (g/dL)		8,9 (0,65)
≥9	26 (47,3)
<9	29 (52,7)
Serum ferritin level (ng/dL)		6440,9 (3908,47)
<2500	5 (9,1)
≥2500	50 (90,9)
Vitamin D 25(OH)D level		16,9 (5,68)
Sufficient	22 (40,0)
Insufficient	22 (40,0)
Deficient	11 (20,0)
Calcium level		1,1 (0,06)
Normal	54 (98,2)
Hypocalcemia	1 (1,8)

Anthropometric and body composition characteristics of the male adolescent with TM are shown in Table 2. The male and female groups had significant differences in the measurements of MUAC, TSK, percentage of fat mass, and percentage of muscle mass.

Table 2

Anthropometric and Body Composition Characteristics
Variable	Male	Female	p	Total
Weight (kg)	34 (SD 8,65)	37,7 (SD 9,02)	0,210	6,1 (SD 8,96)
Height (cm)	143,4 (SD 12,07)	141,5 (SD 9,50)	0,508	142,4 (SD 10,74)
MUAC (cm)	19,3 (SD 2,13)	21,2 (SD 3,00)	0,010	20,3 (SD 2,78)
TSK (mm)	8 (7,00–10,12)	10 (8,00–14,00)	0,014	8,3 (8,0–11,50)
MUAMC (mm)	169,4 (149,42–184,88)	179,2 (154,41–199,47)	0,066	174,3 (152,04-185,46)
% Fat mass DXA	19,1 (SD 4,78)	32,1 (SD 7,11)	< 0,001	25,9 (SD 8,90)
% Muscle mass DXA	80,8 (SD 4,75)	67,9 (SD 7,11)	< 0,001	74,0 (SD 8,89)
Z BMD	-1,7 (SD 0,76)	-1,58(SD 0,77)	0,334	-1,7 (SD 0,77)
*Median (interquartile range), Mean (Standard Deviation)

Tabel 3. Male TM Nutritional Intake and Needs

Variable	Nutritional Intake	Nutritional Needs	Adequacy percentage
Energy (kcal)	1970,4 (SD 394,13)	2339,6 (SD 302,08)	85,6 (SD 20,19)
Protein (g)	63 (SD 14,11)	116,9 (SD 15,10)	55 (SD 14,69)
Fat (g)	86,1 (SD 23,44)	77,9 (SD 10,07)	112,4 (SD 35,48)
Carbohydrates	246,6 (SD 59,61)	292,4 (SD 37,76)	85,5 (SD 23,31)
Vitamin D (mcg)*, median (RIK)	4,3 (2,35 − 6,13)	15	29 (15,68 − 40,80)
Vitamin E (mg) *, median (RIK)	4,10(3,55 − 6,20)	15,0 (11,00–15,00)	34,1 (SD 14,77)
Calcium (mg) *, median (RIK)	444,2 (199,3-521,3)	1200	37 (16,63 − 43,45)
Folic acid (mcg)	145,5 (SD 58,39)	400	36,4 (SD 14,60)
*Median (interquartile range), Mean (Standard Deviation)

The average energy adequacy of male TM adolescents is 85.6% (SD 20.19), while the female adolescent is 93.6% (SD 18.61). The average fat intake in both groups was higher than the RDA requirement, while protein intake was lower (Tables 3 and 4). In addition, both groups found that micronutrient intake, vitamin D, vitamin E, calcium, and folic acid intake were low.

Table 4

Female TM Nutritional Intake and Needs
Variable	Nutritional Intake	Nutritional Needs	Adequacy percentage
Energy (kcal)	1881,3 (SD 353,29)	2023,4 (SD 193,40)	93,6 (SD 18,61)
Protein (g)	59,5 (SD 12,29)	101,1 (SD 9,67)	59 (51–63)
Fat (g)	84,9 (SD 19,35)	67,4 (SD 6,45)	118 (105–142,5)
Carbohydrates	233,2 (SD 57,07)	252,9 (SD 24,17)	93,3 (SD 25,50)
Vitamin D (mcg)*, median (RIK)	3,3 (2,05–6,45)	15	22 (13,65 − 43)
Vitamin E (mg) *, median (RIK)	3,6 (3,25 − 5,95)	15	24 (21,65 − 39,7)
Calcium (mg) *, median (RIK)	427,8 (245,3-667,4)	1200	35,7 (20,45–55,6)
Folic acid (mcg)	105,2 (64,75–164,5)	400	26,3 (16,2–41,15)
*Median (interquartile range), Mean (Standard Deviation)

The correlation between macronutrient intake and body composition in male and female TM adolescents is described in Table 5 and Table 6. There is a mild correlation between energy intake and fat mass percentage in both groups. However, there is no correlation between carbohydrate, fat, and protein intake with the percentage of muscle mass, fat mass, and z BMD.

Table 5

The Correlation Between Macronutrient Intake and Body Composition in Male TM
Variable	%Muscle mass		%Fat mass		Z BMD
Variable	r	p	r	p	r	p
Energy (%)	0,09	0,663^	0,25	0,017^	0,21	0,310^
Carbohydrates (%)	-0,11	0,575^	0,40	0,214^	0,10	0,622^
Fat (%)	0,24	0,235^	0,02	0,892^	0,27	0,171^
Protein (%)	0,05	0,814^	0,18	0,377^	0,03	0,872^
*Spearman correlation test;^ Person correlation test

Table 6

The Correlation Between Macronutrient Intake and Body Composition in Female TM
Variable	%Muscle mass		%Fat mass		Z BMD
Variable	r	p	r	p	r	p
Energy (%)	0,15	0,421^	0,38	0,020^	-0,29	0,124^
Carbohydrates (%)	0,33	0,082^	0,43	0,055^	-0,26	0,167^
Fat (%)	0,11	0,580*	-0,15	0,436*	-0,37	0,057*
Protein (%)	0,06	0,752*	-0,09	0,613*	-0,23	0,217*
*Spearman correlation test;^ Person correlation test

The correlation between micronutrient intake and body composition is shown in Tables 7 and 8. There was no correlation between vitamin D, vitamin E, calcium, and folic acid intake on fat mass, muscle mass, and BMD in both male and female groups.

Table 7

The Correlation Between Micronutrient Intake and Body Composition in Male TM
Variable	%Muscle mass		%Fat mass		Z BMD
Variable	r	p	r	p	r		p
Vitamin. D (%E)	0,13	0,522*	-0,13	0,522*		0,13		0,505*
Vitamin. E (%E)	0,30	0,135^	-0,30	0,133^		0,51		0,480^
Calcium (%E)	-0,09	0,638*	0,09	0,638*		-0,16		0,442*
Folic Acid (%E)	-0,10	0,620^	0,09	0,640^		-0,02		0,924^
*Spearman correlation test;^ Person correlation test

Table 8

The Correlation Between Micronutrient Intake and Body Composition in Female TM
Variable	%Muscle mass				Z BMD
Variable	r	p	r	p	r	p
Vitamin D (%E)	-0,22	0,251*	0,04	0,824*	0,08	0,685*
Vitamin E (%E)	-0,27	0,144*	0,02	0,903*	-0,16	0,400*
Calcium (%E)	-0,19	0,324*	0,05	0,761*	0,01	0,968*
Folic acid (%E)	-0,01	0,933*	-0,18	0,357*	0,04	0,852*
*Spearman correlation test;^ Person correlation test

The correlation between vitamin D levels and body composition are shown in Tables 9 and 10. However, there was no correlation between vitamin D levels and the percentage of muscle mass, fat mass, and z-BMD.

Table 9

The Correlation Between Vitamin D Levels and Body Composition in Male TM
Variable	%Muscle mass		%Fat mass		Z BMD
Variable	r	p	r	p	r	p
Vitamin D (ng/mL)	0,105	0,610^	-0,106	0,606^	0,381	0,055^
*Spearman correlation test;^ Person correlation test

Table 10

The Correlation Between Vitamin D Levels and Body Composition in Female TM
Variable	%Muscle mass		%Fat mass		Z BMD
Variable	r	p	r	p	r	p
Vitamin D (ng/mL)	0,115	0,552^	-0,115	0,552^	0,101	0,603^
*Spearman correlation test;^ Person correlation test

This study found that 58.2% of the subjects had moderate malnutrition, and 9.1% had severe malnutrition based on the MUAC. On the other hand, when nutritional status was assessed based on weight/height, 23.6% of the subjects had moderate malnutrition, 76.4% had optimal nutritional status, and none experienced severe malnutrition. The enlarged spleen can influence this difference in most research subjects. Enlarged spleen around 3–10 cm was found in 35 subjects (65%), while enlarged spleen less than 3 cm and more than 10 cm were found in 6 (10%) and 14 (25%) subjects, respectively. This discrepancy finding further strengthens the recommendation of using the MUAC measurement according to age based on the Frisancho table to assess nutritional status in patients with organomegaly.¹⁵

More than half of the subjects in this study were malnourished. If an evaluation was carried out based on weight/age, only 15 subjects (27.3%) achieved the weight/age target in the 10-90th percentile range, while 40 subjects (72.7%) were below the 10th percentile of the weight/age chart. It is different if the evaluation of nutritional status is based on BMI calculations; it is found that 34 subjects achieved BMI targets in the 10-80th percentile range, while 18 subjects had BMI < 5 percentile (severe malnutrition). Growth failure is one of the most frequently reported complications in children and adolescents with TM. The growth deficit in children with TM can range from 20–65%, according to the severity of the disease.¹⁶ Several reasons cause children with chronic diseases to be at risk for malnutrition, including increased caloric needs, malabsorption, changes in nutrient utilization, and limitations in providing nutrition due to fluid status and/or food tolerance.¹⁷

This study found 58.2% short stature subjects. Short stature is a common clinical condition seen in TM patients. A recent meta-analysis study conducted worldwide showed that 48.9% of TM patients were short of stature.¹⁸ Various factors such as chronic anemia, growth hormone deficiency, and hypogonadism contribute to decreased bone size in TM patients.⁴⁶ Moiz et al.'s study of 367 children aged 6–17 years with transfusion-dependent β-thalassemia in Pakistan found that 65% of the study subjects were short-stature.¹⁹

As many as 40% of subjects in this study had vitamin D insufficiency, 20% of subjects had vitamin D deficiency, and 20% of subjects had sufficient vitamin D levels. Merchant et al.'s study also showed that 62% of subjects had low vitamin D levels.²⁰ Decreased vitamin D levels in TM patients can be caused by impaired hydroxylation of vitamin D in the liver due to hemochromatosis, nutritional deficiencies, and reduced vitamin D production in the skin due to lack of sun exposure to limited activity or dark skin color. ^48,50

On anthropometric examination, there were significant differences between the male and female groups in the MUAC and TSK assessments. Body composition assessment based on DXA also found differences, where the percentage of muscle mass in the male group was higher than in the female group, whereas the percentage of fat mass in the female group was higher than in the male subject. The difference in muscle mass and fat composition is in line with the physiology of growth and development during adolescence. In normal growth, boys gain muscle mass and fat-free tissue, more muscle and lean tissue at puberty, while girls gain fat mass.²¹

In this study, the average muscle and fat mass percentage in TM adolescents was 74.1% and 25.9%, respectively. These results are not different from the study of Elalfy et al.²² in Iran in 2021, which was conducted on 74 TM patients and obtained the average percentage of muscle mass and fat mass of 68.8% and 24.4%, respectively. However, slightly different results were obtained in the study of Tellioglu et al.²³ in Turkey who got the average percentage of muscle mass and fat mass of 67.8% and 32.1% in TM patients, while in the normal population, the average percentage of muscle mass and fat mass was 73, 3% and 35%. This difference could be due to the broad age range (4–36 years) and the difference in the tools used, the BIA method. However, this study found differences in body composition between TM patients and the normal population, where TM patients had lower measures of weight, height, waist circumference, and muscle mass.

Most adolescent TM patients are malnourished despite getting adequate energy intake. Therefore, it proves that the energy needs of adolescent TM are higher than the normal population. Furthermore, TM patients require high calorie and protein intake. The results of this study are slightly different from those of Elalfy et al. ²² on 200 subjects with β-thalassemia major children in Egypt who had significantly lower nutritional intake in terms of the number of calories, protein, carbohydrates, and micronutrient intakes such as calcium and phosphate compared to controls.

The study found an unbalanced diet consumption pattern, where adolescent TM patients received low protein and carbohydrate intake. On the contrary, excessive intake of fat intake was found. The TIF guidelines generally emphasize the importance of providing optimal and balanced dietary intake.⁵ The findings in this study also strengthen the recommendation to provide high calorie and protein intake, but with a fat intake that is still limited to 15–30% of total calories.¹⁴

The study found low intakes of vitamin D, vitamin E, calcium, and folic acid. The adequacy of micronutrient intake is based on the RDA recommended by the Indonesian Ministry of Health in 2019, which is in line with the guidelines issued by the United States Department of Agriculture (USDA) in 2020.^24,25 Although the administation of vitamin E and folic acid supplementation has included in the dr. Cipto Mangunkusumo National Hospital Jakarta thalassemia clinic clinical practice guideline, due to the problem with the availability of drugs that are not covered by National Health Insurance, some patients with TM do not take the supplementation regularly. The TM patients' low intake was similarly found by Fung et al.²⁶ that more than 30% of study subjects consumed inadequate levels of vitamins A, D, E, K, folate, calcium, and magnesium.

Energy intake in this study had a mild correlation with the fat mass percentage in the male group (r = 0.25, p = 0.017) and the female group (r = 0.38, p = 0.020). This is in accordance with the diet analysis results, which have a high fat intake. This study showed that carbohydrate, protein, and fat intake were not correlated with adolescent TM body composition. Lack of energy for a long time in TM patients can cause nutritional deficiencies that can interfere with child development. In another study, although dietary intake appeared to be adequate and without complications of endocrinopathy or cardiomyopathy, TM patients were malnourished, as indicated by significantly smaller MUAC and TSK sizes than their peers. Hypermetabolic status in TM children impacts an increased resting metabolic rate and oxygen consumption due to anemia, increased heart work, and bone marrow hyperactivity. The combination of normal intake and increased metabolic rate per kilogram of body weight reduces the energy available for growth. This condition can be proven by significantly lower serum albumin and IGF-1 levels in thalassemia patients compared to the normal population.²⁷

Micronutrient intake is thought to be one of the factors influencing body composition in adolescents with thalassemia major. In this study, no correlation was found between the intake of these micronutrients and body composition. Vitamin D levels are one of the factors thought to play a role in shaping body composition. This study found no correlation between vitamin D levels and the percentage of muscle mass, fat mass, and BMD. Different results were obtained in the study of Singh et al.,²⁸ which showed a significant correlation between the Z BMD score of the lumbar spine and vitamin D levels (r = 0.422, p = 0.031). The study of Singh et al. used a large sample of 150 subjects. The difference in results with the study of Singh et al. may be due to differences in the number of samples. The absence of a correlation between vitamin D levels with muscle mass and BMD in this study may be due to generally low vitamin D levels in research subjects and the presence of other factors besides vitamin D levels, such as nutritional intake, physical activity, and hormones.²⁸

This is the first study in Indonesia to assess body composition and nutritional intake in adolescent TM patients. Previous studies on body composition in pediatric patients with thalassemia major by Koor et al.²⁹ used research samples with an age range of 8–17 years, while Elalfy et al.²² used young adult subjects (14–28 years). Body composition was checked using the DXA tool, which is the gold standard. Nutritional intake was assessed using a food record for three days, two working days and one day on weekend, to describe the actual diet pattern and compare the patient's nutritional intake with the RDA standard value. The limitations of this study did not include other factors that can affect body composition, such as hormonal factors and the role of physical activity. The assessed micronutrient intake was also limited to the intake of vitamin D, vitamin E, calcium, and folic acid, which have become part of the supportive management of TM patients at dr. Cipto Mangunkusumo National Hospital Jakarta. This study assessed micronutrient levels based on dietary intake without assessing blood levels, except for calcium and vitamin D levels.

More than half of adolescent TM patients are malnourished and lack protein intake. Body composition was slightly correlated with energy intake but not other macronutrients and micronutrients. Vitamin D levels did not correlate with body composition. Mid-upper arm circumference and MUAMC were moderate to strongly correlated with fat mass and muscle mass percentage.

Suggestion

Based on the results of this study, researchers suggest increasing the intake of macronutrients, especially protein and micronutrients, according to the recommendation and monitoring nutritional status regularly in adolescent TM patients. In addition, MUAC examination can be a parameter to assess the body composition of adolescent TM patients.

Disclosures

There is no potential conflict of interest relevant to this article.

1. Consent to Participate Declaration

The confidentiality and privacy of participants in this study are of utmost importance. All legal guardians of individuals included in this study were assured of the confidentiality of their data. Written informed consent was obtained from each legal guardian, emphasizing that no personal identifiers, such as names or affiliations, will be disclosed in any publication resulting from this study. There was no financial benefit from the company associated with the submission or publication of this manuscript.

2. Funding Declaration

This study was funded by PUTI Pascasarjana Universitas Indonesia, with number NKB-196/UN2.RST/HKP.05.00/2022.

3. Ethics Approval and Consent to Participate Declaration

Ethical considerations were carefully considered in the planning and implementation of this study. The study protocol was approved by the Ethics Committee, Faculty of Medicine, University of Indonesia with approval number: KET-99/UN2.F1/ETIK/PPM.00.02/2022. All legal guardians of the subjects participating in the study provided informed consent before participating in the study.

4. Authors' Contributions:

Agus Fitrianto: Conceptualization, methodology, investigation, data analysis and interpretation, software, and writing original draft preparation

Pustika Amalia Wahidiyat : data analysis, supervision, validation, and writing original draft preparation

Titis Prawitasari : data curation, methodology, editing, and supervision

Damayanti Sekarsari : validation and reviewingAll authors read and approved the final manuscript.

5. Clinical Trial Number

This study was not clinical trial study. This study was cross sectional study.

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No competing interests reported.

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Correlation between Nutritional Intake and Body Composition in Adolescents with Thalassemia Major

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