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Role of Levocarnitine supplementation on recovery in children with Complicated Severe Acute Malnutrition

Role of Levocarnitine (L-Carnitine) Supplementation on recovery in children with Complicated Severe Acute Malnutrition: A Randomized Double Blind Placebo Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046683
Enrollment
190
Registered
2022-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E43- Unspecified severe protein-caloriemalnutrition

Interventions

Intervention1: Syp. Levocarnitine: All children 6 months to 5 years will receive syp. levocarnitine @100mg/kg/day for 3 months in 3 divided doses Control Intervention1: Placebo Syp. similar to Syp. Le

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children 6 months-5 years fulfilling the WHO criteria for complicated severe acute malnutrition will be included. Complicated severe acute malnutrition is defined as children with clinical features of infection, severe anemia, metabolic disturbances, edema, hypothermia, vomiting, severe dehydration or a lack of apetitie

Exclusion criteria

Exclusion criteria: 1. Children with congenital heart disease and acquired heart disease 2. Children with chronic organ dysfunction 3. Children with congenital malformations 4. Children with chromosomal anomalies 5. Children with inborn errors of metabolism 6. Children already taking levocarnitine supplementation will be excluded

Design outcomes

Primary

MeasureTime frame
Proportion of children with weight for height more than -2 Z ScoreTimepoint: 6 months after intervention

Secondary

MeasureTime frame
1. Time to Recovery 2. Duration of Hospital Stay 3. Mortality 4. Brain Natriuretic Peptide, Creatinine Kinase MB and CTrop I 5. Left ventricular Mass, left ventricular mass index, ejection fraction and fractional shortening 6. Relapse rateTimepoint: 3 months and 6 months 3 months and 6 months 3 months and 6 months

Countries

India

Contacts

Public ContactDr Sumaira Khalil

University College of Medical Sciences and GTB Hospital

sumairakhalil@yahoo.com9810424664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026