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Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition

NCT04323059 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-03-30

No results posted yet for this study

Summary

This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".

Conditions

  • Malnutrition; Moderate

Interventions

DIETARY_SUPPLEMENT

Standardized milk-based formulation

Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition

Sponsors & Collaborators

  • Dr. Ekong E. Udoh

    lead OTHER

Principal Investigators

  • Ekong E Udoh, FWACPaed · University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria

  • Sunday B Adesina, FWACPaed · University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria

  • Blessing N Nwazuluoke, BSc · University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-10-31
Completion
2020-11-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323059 on ClinicalTrials.gov