CompletedPhase 3

Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent

Bangladesh268 participantsStarted 2007-11

Plain-language summary

The purpose of this study is to determine the safety profile of oral iron supplementation (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID) and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.

Who can participate

Age range1 Year – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children aged 12 - 24 months * moderate to severe malnutrition (MSM), defined as weight-for-age Z-score ≤ -2 based on the National Center for Health Statistics (NCHS) standards Exclusion Criteria: * severe anemia (hemoglobin ≤70g/L) * near normal hemoglobin concentration (\>100g/L) * weight-for-height \<-3 z-score (severe wasting) * kwashiorkor (defined as evidence of edema) * congenital abnormality or disease * treatment with iron supplements in the past 3 months * inclusion in a nutrition program in the past * chronic illness other than malnutrition.

What they're measuring

A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections

Timeframe: 2 distinct and consecutive phases of 6 months each

Trial details

NCT IDNCT00530374

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

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