L-Carnitine Supplementation, Rate of Weight Gain and EED in Children With SAM

NCT05083637 | Completed DMC

• 1 other identifier: PR-21046
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Burden: Globally, an estimated 14.3 million under-5 children are severely malnourished. Two-thirds of them live in Asian countries, including Bangladesh. Acute malnutrition is an underlying cause of nearly half of global deaths in under-5 children despite standardized rehabilitation protocols. It is also associated with high relapse rates following discharge. Knowledge Gap: Malnourished children suffer from deficiencies of several essential nutrients. Studies showed that malnourished children had lower serum carnitine levels and demonstrated its role in the rate of weight gain in children with severe acute malnutrition (SAM). The consequences of nutritional impairment can be perilous if carnitine deficiency is coupled with Environmental Enteric Dysfunction (EED). Recent evidence confirms that EED is characterized by secondary carnitine deficiency in children. Carnitine deficiency leading to EED may cause childhood growth faltering and impaired cognitive development. However, evidence on carnitine status and its consequences in relation to EED in diarrheal children with SAM is very limited in Bangladesh. Relevance: Such lack of information regarding the role of L-carnitine in improving the rate of weight gain in malnourished children susceptible to EED is an obstacle in limiting the relapse and adverse consequences of SAM in diarrheal children living in resource-limited countries. Hypothesis: L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED Objective:

1. 1.To investigate the role of L-carnitine supplementation on the rate of weight gain among the children with SAM
2. 2.To investigate the role of L-carnitine supplementation on the duration of the hospital stays
3. 3.To examine the role of L-carnitine supplementation on EED biomarkers, for instance, myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine: tryptophan (KT) ratio, and citrulline in children with SAM

Conditions

Malnutrition

Keywords

Malnutrition; L-Carnitine; Environmental Enteric Dysfunction; Under-5 children; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Rate of weight gain

  The rate of weight gain (g/kg/day) will be calculated by using the formulae below: \[{Weight on completion of study - Weight on enrolment (or at no edema) (g)} / {Total duration (in days) \* weight on enrolment in kg}\]

  Baseline to 15th day of treatment

Secondary Outcomes (2)

• Duration of hospital stays

  Baseline to 15 days of treatment

• EED biomarkers [myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine: tryptophan (KT) ratio, and citrulline]

  Baseline to 15 days of treatment

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Children randomized to this arm will receive L- carnitine oral solution (100mg/ml) (Generic Name) with the dosage- 100 mg/kg/day, divided into 3 doses per day for 15 days.

Drug: L- carnitine oral solution

Control Arm

PLACEBO COMPARATOR

Children randomized to this arm will receive placebo in same quantity, divided into 3 doses per day for 15 days.Placebo solution will be identical in appearance, smell and taste to the active preparation (L-carnitine syrup) with no therapeutic value.

Other: Placebo

Interventions

L- carnitine oral solution DRUG

The L-carnitine syrup formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up

Also known as: Levocarnitine oral solution

Intervention Arm

Placebo OTHER

The placebo formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up

Control Arm

Eligibility Criteria

• Age: 9 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diarrheal children with SAM aged 9-24 months
• Signed informed consent by the guardian/caregivers

You may not qualify if:

• Severe sepsis or Septic shock
• Patients already taking medications containing L- carnitine
• Children with Tuberculosis
• Children with congenital defects or chromosomal anomalies
• Children with a diagnosed case of Thalassemia
• Children with an active or previous history of convulsion

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital; International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (3)

• Alp H, Orbak Z, Akcay F, Tan H, Aksoy H. Plasma and urine carnitine levels and carnitine supplementation in children with malnutrition. J Trop Pediatr. 1999 Oct;45(5):294-6. doi: 10.1093/tropej/45.5.294.

  PMID: 10584472 BACKGROUND

• Alam J, Fahim SM, Islam MR, Alam MA, Gazi MA, Ahmed T. Effects of L-Carnitine Supplementation on the Rate of Weight Gain and Biomarkers of Environmental Enteric Dysfunction in Children with Severe Acute Malnutrition: A Double-Blind Randomized Controlled Clinical Trial. J Nutr. 2024 Mar;154(3):949-961. doi: 10.1016/j.tjnut.2024.01.031. Epub 2024 Feb 6.

  PMID: 38331348 DERIVED

• Alam J, Islam MR, Fahim SM, Gazi MA, Ahmed T. Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial. PLoS One. 2022 Sep 30;17(9):e0275291. doi: 10.1371/journal.pone.0275291. eCollection 2022.

  PMID: 36178918 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Jinat Alam, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: October 19, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: March 7, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)