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

Study Overview
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Brief Summary
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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.

Detailed Description
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Iron deficiency (ID) affects many children in developing countries. Anemia and impaired brain development are its most significant consequences. These may be prevented by giving oral iron supplements (OIS), such as Sprinkles. ID treatment was controversial because high dose parenteral iron therapy is strongly associated with severe infections when given to severely malnourished children. Many studies have since demonstrated the safety of low dose OIS. WHO guidelines reflect this finding: population-wide iron supplementation campaign (PWISC), without prior screening, is recommended when ID prevalence is ≥ 40%. However, a gap in the safety evidence has been identified: children with moderate or severe malnutrition (MSM) are strikingly absent from the studies performed to date to investigate the link between OIS and infectious morbidities. In this context, PWISC may have unrecognized deleterious effects when the prevalence of MSM is high, since safety is assumed, but incorrectly extrapolated from available evidence. We wish to emphasize an additional concern with regards to safety studies published thus far: all were designed as superiority trials. In this context, it is statistically incorrect to conclude that failure to show a significant difference between iron and placebo means that their respective side-effect profiles are similar.

Official Title
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Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial

Conditions
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Malnutrition, Iron Deficiency

Intervention / Treatment
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* Dietary Supplement: Oral Iron Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days | Dietary Supplement: Oral Iron Supplement<br>* Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days<br>* Other names: Sprinkles;|
| Placebo Comparator: 2<br>Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days | Dietary Supplement: Placebo<br>* Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days<br>* Other names: Placebo Sprinkles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections |  | 2 distinct and consecutive phases of 6 months each | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death and fever without a source [Safety] |  | 2 distinct and consecutive phases of 6 months each | 
| Change in haemoglobin concentration after Sprinkles supplementation [Efficacy] |  | 2 distinct and consecutive phases of 6 months each | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Malnutrition, Iron Deficiency, Sprinkles, Oral Iron Supplementation