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

This study has been completed.
Sponsor:
Collaborators:
Bangladesh Rural Advancement Committee
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00530374
First received: September 13, 2007
Last updated: May 25, 2009
Last verified: May 2009
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • A composite score based on the sum of all distinct episodes of diarrhea, dysentery and lower respiratory tract infections [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of death and fever without a source [Safety] [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]
  • Change in haemoglobin concentration after Sprinkles supplementation [Efficacy] [ Time Frame: 2 distinct and consecutive phases of 6 months each ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Name: Sprinkles
Placebo Comparator: 2
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
Other Name: Placebo Sprinkles

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.

  Eligibility

Ages Eligible for Study:   1 Year to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530374

Locations
Bangladesh
Village of Shombhuganj
Shombhuganj, Mymensingh district, Bangladesh
Sponsors and Collaborators
The Hospital for Sick Children
Bangladesh Rural Advancement Committee
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00530374     History of Changes
Other Study ID Numbers: 1000009576
Study First Received: September 13, 2007
Last Updated: May 25, 2009
Health Authority: Canada: Ethics Review Committee
Bangladesh: Bangladesh Medical Research Council

Keywords provided by The Hospital for Sick Children:
Pediatrics
Malnutrition
Iron Deficiency
Sprinkles
Oral Iron Supplementation

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Malnutrition
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014