Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
NCT ID: NCT04995874
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
649 participants
INTERVENTIONAL
2021-08-06
2022-06-25
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Control
This arm will receive no supplement and no placebo for the duration of the study.,
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
6 Months
18 Months
ALL
Yes
Sponsors
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International Food Policy Research Institute
OTHER
Noguchi Memorial Institute for Medical Research
OTHER
Responsible Party
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Principal Investigators
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Gloria K Folson
Role: PRINCIPAL_INVESTIGATOR
Noguchi Memorial Institute for Medical Research
Locations
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37 Military Hospital
Accra, Greater Accra Region, Ghana
Greater Accra Regional Hospital
Accra, Greater Accra Region, Ghana
Korle-bu Teaching Hospital
Accra, Greater Accra Region, Ghana
Princess Marie Louise Children's Hospital
Accra, Greater Accra Region, Ghana
Ashaiman Polyclinic
Ashaiman, Greater Accra Region, Ghana
Tema General Hospital
Tema, Greater Accra Region, Ghana
Countries
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Central Contacts
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Facility Contacts
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Philip Nyinaku
Role: primary
Salomey Frimpong
Role: primary
Joycelyn Assiment Dame
Role: primary
Margaret Niezer
Role: primary
Adwoa Amoako
Role: primary
Richard Anthony
Role: primary
Other Identifiers
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2021X018.NMI
Identifier Type: -
Identifier Source: org_study_id