Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

Noguchi Memorial Institute for Medical Research649 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

649

Conditions

HIV Infections Nutrition Poor Child Development

Interventions

KOKOPlus protein and micronutrient powderDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

37 Military Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Greater Accra Regional Hospital

Accra, Greater Accra Region, Ghana

RECRUITING

Korle-bu Teaching Hospital

Accra, Greater Accra Region, Ghana

Outcomes

Primary Outcomes

Anthropometry

Length-for-age Z score, Weight-for-age Z score. Weight for length Z score

Time frame: 6 months

Haemoglobin

(g/dl), anaemia

Time frame: 6 months

Child developmental Milestones achieved

Time frame: 6 months

Secondary Outcomes

Morbidity

Incidence of fever, malaise, loss of appetite

Time frame: 6 months

Central Contacts

Gloria K Folson

CONTACT

+233550006053 gfolson@noguchi.ug.edu.gh

Grace S Tokor

CONTACT

+233243009116 gracetokor@gmail.com

Data from ClinicalTrials.gov

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