Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra

November 5, 2021 updated by: Noguchi Memorial Institute for Medical Research
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

649

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ghana
    • Greater Accra
      • Accra, Greater Accra, Ghana
        • Recruiting
        • 37 Military Hospital
        • Contact:
      • Accra, Greater Accra, Ghana
        • Recruiting
        • Greater Accra Regional Hospital
        • Contact:
      • Accra, Greater Accra, Ghana
        • Recruiting
        • Korle-Bu Teaching Hospital
        • Contact:
      • Accra, Greater Accra, Ghana
        • Recruiting
        • Princess Marie Louise Children's Hospital
        • Contact:
      • Ashaiman, Greater Accra, Ghana
        • Recruiting
        • Ashaiman Polyclinic
        • Contact:
      • Tema, Greater Accra, Ghana
        • Recruiting
        • Tema General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.
No Intervention: Control
This arm will receive no supplement and no placebo for the duration of the study.,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometry
Time Frame: 6 months
Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
6 months
Haemoglobin
Time Frame: 6 months
(g/dl), anaemia
6 months
Child developmental Milestones achieved
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 6 months
Incidence of fever, malaise, loss of appetite
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noguchi Memorial Institute for Medical Research

Collaborators

International Food Policy Research Institute

Investigators

  • Principal Investigator: Gloria K Folson, Noguchi Memorial Institute for Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Anticipated)

June 25, 2022

Study Completion (Anticipated)

June 25, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021X018.NMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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