NCT04995874

Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 649 (estimated)
• Sponsor: Noguchi Memorial Institute for Medical Research · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

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

Detailed description

The specific objectives are to accomplish the following 1. To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months. 2. To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months 3. To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels. 4. To measure and compare morbidity rates of intervention and control arms. 5. To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI). 6. To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion

Conditions

• HIV Infections
• Nutrition Poor
• Child Development

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-06
• Primary completion: 2022-06-25
• Completion: 2022-06-25
• First posted: 2021-08-09
• Last updated: 2021-11-15

Locations

6 sites across 1 country: Ghana