PACTR202105499634368
Completed
Phase 2
Randomized Controlled Trial to Compare the Effect of Corn-Soy Blend + Vegetable Oil and Fish Oil (CSB-VO-FO) With Corn-Soy Blend + Vegetable Oil Alone (CSB-VO) on the Immunological and Microbiota Patterns among Children Aged 9 to 24 months with Moderate Acute Malnutrition (MAM)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kenya Medical Research Institute
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Resident and living within Kibera Slums in Nairobi for the duration of the study.
- •Aged 9\-24 months.
- •With MAM, defined as mid\-upper arm circumference (MUAC) of 11\.5 to \<12\.5cm.
- •Caregiver is able and willing to provide informed consent.
Exclusion Criteria
- •Severe acute malnutrition (SAM) WLZ\< \-3 and/or MUAC \< 11\.5 cm.
- •Chronic malnutrition: Length\-for\-age z\-score (LAZ) \<\-3\.
- •Clinically diagnosed severe anemia.
- •Other chronic illnesses such as AIDS and malignancy.
- •HIV positive; based on National Guidelines for HIV testing in Kenya.
- •History of TB or malignancy.
- •Clinically diagnosed active infections in the past one week such as: Pneumonia, Gastroenteritis, Urinary tract infections or Meningitis.
- •Temperature \>37\.5°C.
- •Gross Congenital abnormalities
Outcomes
Primary Outcomes
Not specified
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