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Clinical Trials/PACTR202105499634368
PACTR202105499634368CompletedPhase 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)

Kenya Medical Research Institute0 sites80 target enrollmentStarted: April 13, 2021Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
80

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
1 Month(s) to 23 Month(s) (—)
Sex
All

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

Investigators

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