![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
The Hospital for Sick Children Bangladesh Rural Advancement Committee International Centre for Diarrhoeal Disease Research, Bangladesh |
---|---|
Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00530374 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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
|
2: Placebo Comparator
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
|
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.
Ages Eligible for Study: | 1 Year to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stanley Zlotkin, MD | 416-813-6171 | stanley.zlotkin@sickkids.ca |
Bangladesh, Mymensingh district | |
Village of Shombhuganj | Recruiting |
Shombhuganj, Mymensingh district, Bangladesh | |
Contact: Marufa Aziz Khan | |
Principal Investigator: Stanley Zlotkin, MD | |
Sub-Investigator: Mathieu Lemaire, MD |
Principal Investigator: | Stanley Zlotkin, MD | The Hospital for Sick Children, Toronto Canada |
Responsible Party: | The Hospital for Sick Children ( Stanley Zlotkin/Principal Investigator ) |
Study ID Numbers: | 1000009576 |
Study First Received: | September 13, 2007 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00530374 |
Health Authority: | Canada: Ethics Review Committee; Bangladesh: Bangladesh Medical Research Council |
Pediatrics Malnutrition Iron Deficiency Sprinkles Oral Iron Supplementation |
Metabolic Diseases Malnutrition Hematologic Diseases Anemia Nutrition Disorders |
Iron Metabolism Disorders Metabolic disorder Iron Anemia, Iron-Deficiency |
Anemia, Hypochromic |