Evaluating the effectiveness of a legume-enriched nutritional intervention, in treatment of severe undernutrition in childre

Not Applicable

Completed

• Conditions: Severe acute malnutrition; Nutritional, Metabolic, Endocrine; Malnutrition

• Registration Number: ISRCTN10309022
• Lead Sponsor: Imperial College London

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30345381 protocol 2023 Results article in https://doi.org/10.12688/wellcomeopenres.16771.2 (added 07/03/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38831516/ (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Study Completion: 2019-09-01
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Marasmus defined by mid-upper arm circumference < 11.5cm
2. Kwashiorkor defined as symmetrical pitting oedema involving at least the feet irrespective of WHZ score or MUAC
3. Guardian/parent willing and able to provide consent

Exclusion Criteria

Children with severe acute malnutrition with very high risk of death due to comorbidity, e.g. malignant disease or terminal illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mid-upper arm circumference in centimeters and millimeters measured using measuring tape supplied by UNICEF designed for this purpose on admission (at trial recruitment), day 7, day 28 and day 90<br>2. Survival recorded by incidence of death up to day 90