Trial | NCT00530374  Report issue

Title

Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent
Impact of Oral Iron Supplementation With Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent - A Non-Inferiority Safety Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    iron ...

  • Study Participants

    268
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.
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 Started
Nov 30
2007
Primary Completion
Jan 31
2009
Study Completion
Apr 30
2009
Last Update
Apr 19
2021

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 names: Sprinkles

Dietary Supplement Placebo

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

  • Other names: Placebo Sprinkles

1 Active Comparator

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

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.
No Results Posted