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Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

NCT04995874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 649

Last updated 2021-11-15

No results posted yet for this study

Summary

The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra

Conditions

  • HIV Infections
  • Nutrition Poor
  • Child Development

Interventions

DIETARY_SUPPLEMENT

KOKOPlus protein and micronutrient powder

KokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements.

Sponsors & Collaborators

  • International Food Policy Research Institute

    collaborator OTHER

  • Noguchi Memorial Institute for Medical Research

    lead OTHER

Principal Investigators

  • Gloria K Folson · Noguchi Memorial Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2022-06-25
Completion
2022-06-25

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995874 on ClinicalTrials.gov