Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

Noguchi Memorial Institute for Medical Research

Status: Unknown

Conditions: Child Development; HIV Infections; Nutrition Poor

Treatments: Dietary Supplement: KOKOPlus protein and micronutrient powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04995874

2021X018.NMI

Details and patient eligibility

About

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

Full 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

Enrollment: 649 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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649 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: KOKOPlus protein and micronutrient powder

Control

No Intervention group

Description:

This arm will receive no supplement and no placebo for the duration of the study.,