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

Phase 3

Completed

• Conditions: Malnutrition; Iron Deficiency
• Interventions: Dietary Supplement: Oral Iron Supplement; Dietary Supplement: Placebo

• Registration Number: NCT00530374
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Study Start: 2007-11
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oral Iron Supplement	Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days
2	Placebo	Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Village of Shombhuganj; 🇧🇩 Shombhuganj, Mymensingh District, Bangladesh

Village of Shombhuganj

🇧🇩Shombhuganj, Mymensingh District, Bangladesh