Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition Iron Deficiency |
Dietary Supplement: Oral Iron Supplement Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial |
- A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]
- Incidence of death and fever without a source [Safety] [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]
- Change in haemoglobin concentration after Sprinkles supplementation [Efficacy] [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]
| Enrollment: | 268 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days
|
Dietary Supplement: Oral Iron Supplement
Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Other Name: Sprinkles
|
|
Placebo Comparator: 2
Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days
|
Dietary Supplement: Placebo
Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Other Name: Placebo Sprinkles
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Bangladesh | |
| Village of Shombhuganj | |
| Shombhuganj, Mymensingh district, Bangladesh | |
| Principal Investigator: | Stanley Zlotkin, MD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00530374 History of Changes |
| Other Study ID Numbers: | 1000009576 |
| Study First Received: | September 13, 2007 |
| Last Updated: | May 25, 2009 |
| Health Authority: | Canada: Ethics Review Committee Bangladesh: Bangladesh Medical Research Council |
Keywords provided by The Hospital for Sick Children:
|
Pediatrics Malnutrition Iron Deficiency Sprinkles Oral Iron Supplementation |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Malnutrition Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
Nutrition Disorders Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013