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Standardized Corn-Soy Blend with Nutrition Education versus Nutrition Education Alone in Community-based Management of Children Under Five Years of Age with Moderate Acute Malnutritio

Phase 4
Conditions
Nutritional, Metabolic, Endocrine
Registration Number
PACTR202002462358066
Lead Sponsor
niversity of Uyo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
160
Inclusion Criteria

1.Children aged 6 – 59 months with MAM (weight-for-height/age between -2 and -3 Z scores or MUAC 11.5 cm – 12.5 cm).
2.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 Criteria

1.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}
2.Children with feeding difficulties eg. gastroesophageal reflux diseases, cleft palate
3.Children with diarrhea (history of passage of = 3 loose stools/day), signs of dehydration or loss of appetite will be considered as complication of malnutrition.
4.Children with neurological diseases eg. Cerebral palsy
5.Children less than 6 months or more 59 months of age

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the; <br>•Improvement from baseline of weight-for-height at two weekly intervals for six months follow-up duration. <br>•The compare the proportion of recovery from MAM in the intervention arm versus the control arm.<br>
Secondary Outcome Measures
NameTimeMethod
To determine the;<br>•Change in mid upper arm circumference from baseline<br>•The proportion of non-recovery from MAM<br>•Time-to-recovery from MAM<br>•Time-to-progression from MAM to SAM<br>•Change in serum protein from baseline<br>•Change in haematocrit value from baseline<br>•Change in serum electrolyte, urea and creatinine values from baseline <br>•All-cause- mortality<br>Adverse events<br>
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