Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

HIV Infections Clinical Trial

Official title:

Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995874
• Other study ID #: 2021X018.NMI
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Child Development
• HIV Infections
• Malnutrition
• Nutrition Poor

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