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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530374
• Other study ID #: 1000009576
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Village of Shombhuganj	Shombhuganj	Mymensingh District

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Bangladesh Rural Advancement Committee, International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of death and fever without a source [Safety]		2 distinct and consecutive phases of 6 months each
Secondary	Change in haemoglobin concentration after Sprinkles supplementation [Efficacy]		2 distinct and consecutive phases of 6 months each