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| Name | Class |
|---|---|
| International Food Policy Research Institute | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | This arm will receive no supplement and no placebo for the duration of the study., |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOKOPlus protein and micronutrient powder | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometry | Length-for-age Z score, Weight-for-age Z score. Weight for length Z score | 6 months |
| Haemoglobin | (g/dl), anaemia | 6 months |
| Child developmental Milestones achieved | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Incidence of fever, malaise, loss of appetite | 6 months |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria K Folson | Contact | +233550006053 | gfolson@noguchi.ug.edu.gh | |
| Grace S Tokor | Contact | +233243009116 | gracetokor@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gloria K Folson | Noguchi Memorial Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 37 Military Hospital | Recruiting | Accra | Greater Accra Region | Ghana |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Greater Accra Regional Hospital | Recruiting | Accra | Greater Accra Region | Ghana |
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| Korle-bu Teaching Hospital | Recruiting | Accra | Greater Accra Region | Ghana |
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| Princess Marie Louise Children's Hospital | Recruiting | Accra | Greater Accra Region | Ghana |
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| Ashaiman Polyclinic | Recruiting | Ashaiman | Greater Accra Region | Ghana |
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| Tema General Hospital | Recruiting | Tema | Greater Accra Region | Ghana |
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |