Serum Carnitine Levels in under five children with Moderate and Severe Acute Malnutrition

Title: Serum Carnitine Levels in Under-Five Children with Moderate and Severe Acute

Malnutrition

Aim: To determine and compare serum free carnitine levels in children (6 month-59 months) with

Moderate and Severe Acute Malnutrition as compared to children with normal nutrition

Objectives: Primary: To compare the levels of free carnitine in sera of children with Moderate acute

malnutrition (MAM) and Severe acute malnutrition (SAM) with those with normal nutrition.

Secondary Objectives: 1) To compare proportion of children with carnitine deficiency in children with

MAM & SAM with those with normal nutrition 2) To compare proportion of children with carnitine

insufficiency in children with MAM & SAM with those with normal nutrition 3) To determine the

association between free carnitine levels and lipid profile, total protein and serum albumin in children

with undernutrition 4) To determine the association between free carnitine levels and age, gender,

weight for length/height and mid upper arm circumference in children with undernutrition

Setting: This study will be conducted in the Department of Pediatrics & Department of Biochemistry

of UCMS and GTB Hospital, New Delhi

Collaborating Institution: Department of Genetics & Laboratory, MAMC, New Delhi.

Study design: Comparative Cross-Sectional study

Study duration: 1st August 2025 – 30th November 2026

Sample Size

This is an exploratory study as no previous study has estimated the free carnitine levels in sera of

children with moderate and severe acute malnutrition as per the WHO criteria 2013 [11]. Therefore,

we will be including 30 participants each with moderate and severe acute malnutrition and 30 each

age and sex matched children of normal nutrition with MAM and SAM. Therefore, total sample size

will be 120 children.

PARTICIPANTS:

Inclusion Criteria 1) Cases: All children aged between 6 months to 59 months, visiting pediatric

OPD or admitted in pediatric emergency or pediatric ward will be screened for enrollment. i) Group 1:

Children aged between 6 months-59 months with moderate acute malnutrition (weight for

length/height Z-score between -3 to -2 and/or mid-upper-arm circumference between 11.5 cm-12.5

cm) ii) Group 2: Children aged between 6 months-59 months with severe acute malnutrition (weight

for length/height Z-score <-3 and/or mid-upper-arm circumference <11.5 cm) as per WHO criteria

2013 will be enrolled. 2) Comparison group: Children aged 6 months- 59 months (preferably age and

sex-matched ± 2 month with MAM and SAM) with no undernutrition (weight-for-length Z-score

between -1 to +1, and mid-upper-arm circumference >12.5 cm)

Methods: Baseline assessment of all children will be recorded in a pre-designed case record form.

Anthropometric assessment will be done as per WHO guidelines. Two ml of venous blood sample

will be collected for estimation of lipid profile, serum total protein and serum albumin, 2 ml venous

sample will be collected in plain vial for estimation of serum carnitine levels. Dried blood spot with

heel prick will be collected on filter paper for estimation of acylcarnitine levels.

Outcome Measures: Primary: Serum free carnitine levels

Secondary: 1) Proportion of children with carnitine deficiency 2) Proportion of children

carnitine insufficiency 3) Correlate with lipid profile, total protein and serum albumin 4) Correlate

with age, gender, weight for height and MUAC

Statistical Analysis: All data will be entered in a Microsoft excel sheet and will be analyzed using

Statistical Package for Social Science (SPSS) statistical software. Descriptive statistics will include

proportion for categorical variables and mean (SD) or median (IQR) or arithmetic/geometric mean

(SD) for carnitine levels. Serum carnitine levels will be compared between the two groups using

ANOVA test. Proportion of children with carnitine deficiency between the two groups will be

compared by Chi square test/Fischer test whichever is applicable. Serum carnitine levels will be

correlated with age, gender, weight for height, MUAC, lipid profile, serum albumin and serum total

protein will be analyzed by Pearson’s/Spearmen Correlation. P<0.05 will be the level of statistical

significance.