An interventional study of KOKOPlus protein and micronutrient powder in HIV Infections, Nutrition Poor and Child Development, sponsored by Noguchi Memorial Institute for Medical Research. Status unknown at 6 sites in Ghana. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Noguchi Memorial Institute for Medical Research · Not applicable, Interventional, and Prevention
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
The specific objectives are to accomplish the following
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 649 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Noguchi Memorial Institute for Medical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This arm will receive no supplement and no placebo for the duration of the study.,
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.
Anthropometry
Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
Time frame: 6 months
Haemoglobin
(g/dl), anaemia
Time frame: 6 months
Child developmental Milestones achieved
Time frame: 6 months
Morbidity
Incidence of fever, malaise, loss of appetite
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Jun 2022, 10 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Noguchi Memorial Institute for Medical Research