Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

Not Applicable

• Conditions: HIV Infections; Nutrition Poor; Child Development
• Interventions: Dietary Supplement: KOKOPlus protein and micronutrient powder

• Registration Number: NCT04995874
• Lead Sponsor: Noguchi Memorial Institute for Medical Research

Brief 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

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-06
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-09
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-15
• Primary Completion: 2022-06-25
• Study Completion: 2022-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.

Exclusion Criteria

• Mothers who decline to participate in the study

Children with severe acute malnutrition (mid-upper arm circumference <115 mm or a weight-for-height/length <-3 Z-scores of the WHO growth standards).

Children on hospital admission

Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	KOKOPlus protein and micronutrient powder	KOKOPlus protein and micronutrient powder , a complementary food supplement containing soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix was formulated. Two weeks' supply of KOKOPlus sachets will be given to intervention arm participants every fortnight for 6 months to be mixed into any cereal, soup, stew, or other food given to the children.

Primary Outcome Measures

Name	Time	Method
Child developmental Milestones achieved	6 months
Anthropometry	6 months	Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
Haemoglobin	6 months	(g/dl), anaemia

Secondary Outcome Measures

Name	Time	Method
Morbidity	6 months	Incidence of fever, malaise, loss of appetite

Trial Locations

Locations (6)

Greater Accra Regional Hospital; 🇬🇭 Accra, Greater Accra, Ghana

Princess Marie Louise Children's Hospital; 🇬🇭 Accra, Greater Accra, Ghana

37 Military Hospital; 🇬🇭 Accra, Greater Accra, Ghana

Korle-bu Teaching Hospital; 🇬🇭 Accra, Greater Accra, Ghana

Ashaiman Polyclinic; 🇬🇭 Ashaiman, Greater Accra, Ghana

Tema General Hospital; 🇬🇭 Tema, Greater Accra, Ghana