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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04995874
Other study ID # 2021X018.NMI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 6, 2021
Est. completion date June 25, 2022

Study information

Verified date August 2021
Source Noguchi Memorial Institute for Medical Research
Contact Gloria K Folson
Phone +233550006053
Email gfolson@noguchi.ug.edu.gh
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 649
Est. completion date June 25, 2022
Est. primary completion date June 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 18 Months
Eligibility 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


Intervention

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.

Locations

Country Name City State
Ghana 37 Military Hospital Accra Greater Accra
Ghana Greater Accra Regional Hospital Accra Greater Accra
Ghana Korle-bu Teaching Hospital Accra Greater Accra
Ghana Princess Marie Louise Children's Hospital Accra Greater Accra
Ghana Ashaiman Polyclinic Ashaiman Greater Accra
Ghana Tema General Hospital Tema Greater Accra

Sponsors (2)

Lead Sponsor Collaborator
Noguchi Memorial Institute for Medical Research International Food Policy Research Institute

Country where clinical trial is conducted

Ghana, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anthropometry Length-for-age Z score, Weight-for-age Z score. Weight for length Z score 6 months
Primary Haemoglobin (g/dl), anaemia 6 months
Primary Child developmental Milestones achieved 6 months
Secondary Morbidity Incidence of fever, malaise, loss of appetite 6 months
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