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

NCT ID: NCT00530374

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

Brief 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.

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.

Conditions

Malnutrition; Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days

Group Type: ACTIVE_COMPARATOR

Oral Iron Supplement

Intervention Type: DIETARY_SUPPLEMENT

Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

2

Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

Interventions

Oral Iron Supplement

Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Sprinkles; Placebo Sprinkles

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangladesh Rural Advancement Committee

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stanley Zlotkin

Chief, Global Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley Zlotkin, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Village of Shombhuganj

Shombhuganj, Mymensingh District, Bangladesh

Countries

Bangladesh

References

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.

Reference Type: DERIVED

PMID: 21715512 (View on PubMed)

Other Identifiers

1000009576

Identifier Type: -

Identifier Source: org_study_id