Status:
UNKNOWN
Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition
Lead Sponsor:
Dr. Ekong E. Udoh
Conditions:
Malnutrition; Moderate
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Childhood malnutrition is presently a leading cause of underfive morbidity and mortality globally. The impact of the condition is most severe in the first 1000 days of life with resultant impairment i...
Eligibility Criteria
Inclusion
- Children aged 6 - 59 months with moderate acute malnutrition (weight-for-height between -2 and -3 Z scores or mid upper arm circumference of 11.5 cm - 12.5 cm).
- Children whose parents/guardian consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study.
Exclusion
- Children with chronic illnesses that may affect growth {(cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
- Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
- Children with diarrhoea
- Children with neurological diseases eg. Cerebral palsy
- Children less than 6 months or more 59 months of age
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04323059
Start Date
April 1 2020
End Date
November 1 2020
Last Update
March 30 2020
Active Locations (3)
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1
Primary Health Centre, Okpoediuse
Ibiono Ibom, Akwa Ibom State, Nigeria
2
Primary Health Centre, Adadiah
Uruan, Akwa Ibom State, Nigeria
3
Primary Health centre, Mbak-Etoi
Uyo, Akwa Ibom State, Nigeria