Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition
1 other identifier
interventional
80
1 country
3
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 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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMarch 30, 2020
March 1, 2020
6 months
March 24, 2020
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight-for-height
Improvement in weight-for-height at two weekly intervals
Four months
Secondary Outcomes (2)
Recovery from moderate acute malnutrition
Four month
Adverse events
Four months
Study Arms (3)
Standardized milk-based formulation
EXPERIMENTALFormulation of maize with milk that is rich in methionine
Standardized non-milk based formulation
EXPERIMENTALFormulation of maize with soybeans that is rich in methionine and lysine
Hospital-based formulation
ACTIVE COMPARATORFormulation of maize, milk and soybeans
Interventions
Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Primary Health Centre, Okpoediuse
Ibiono Ibom, Akwa Ibom State, Nigeria
Primary Health Centre, Adadiah
Uruan, Akwa Ibom State, Nigeria
Primary Health centre, Mbak-Etoi
Uyo, Akwa Ibom State, Nigeria
Related Publications (3)
Seetharaman N, Chacko TV, Shankar SLR, Matthew AC. Measuring malnutrition - the roles of Z scores and the composite index of anthropometric failure. Indian Journal of Community Medicine. 2007; 32 (1): 35-39.
BACKGROUNDVijay DW, Bhawesh RD. Ready to use therapeutic food (RUTF): An overview.. Advances in life Sciences and Health. 2015; 2 (1): 1-15.
BACKGROUNDChoudhury N, Ahmed T, Hossain MI, Islam MM, Sarker SA, Zeilani M, Clemens JD. Ready-to-Use Therapeutic Food Made From Locally Available Food Ingredients Is Well Accepted by Children Having Severe Acute Malnutrition in Bangladesh. Food Nutr Bull. 2018 Mar;39(1):116-126. doi: 10.1177/0379572117743929. Epub 2017 Dec 19.
PMID: 29258336BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekong E Udoh, FWACPaed
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
- STUDY DIRECTOR
Sunday B Adesina, FWACPaed
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
- STUDY CHAIR
Blessing N Nwazuluoke, BSc
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DOCTOR
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 26, 2020
Study Start
April 1, 2020
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data will be available for two years after completion of the trial
- Access Criteria
- Any investigator that request for it within the time frame will be given
Individual patient data will be made available to other researchers by the Principal Investigator on request.