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| Name | Class |
|---|---|
| Bangladesh Rural Advancement Committee | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days |
|
| 2 | Placebo Comparator | Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Iron Supplement | Dietary Supplement | Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Zlotkin, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Village of Shombhuganj | Shombhuganj | Mymensingh District | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21715512 | Derived | Lemaire M, Islam QS, Shen H, Khan MA, Parveen M, Abedin F, Haseen F, Hyder Z, Cook RJ, Zlotkin SH. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr. 2011 Aug;94(2):585-93. doi: 10.3945/ajcn.110.009316. Epub 2011 Jun 29. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Placebo | Dietary Supplement | Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days |
|
|
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |