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

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Mymensingh District
      • Shombhuganj, Mymensingh District, Bangladesh
        • Village of Shombhuganj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Placebo Sprinkles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 distinct and consecutive phases of 6 months each

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of death and fever without a source [Safety]
Time Frame: 2 distinct and consecutive phases of 6 months each
2 distinct and consecutive phases of 6 months each
Change in haemoglobin concentration after Sprinkles supplementation [Efficacy]
Time Frame: 2 distinct and consecutive phases of 6 months each
2 distinct and consecutive phases of 6 months each

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
Bangladesh Rural Advancement Committee

Investigators

  • Principal Investigator: Stanley Zlotkin, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (ESTIMATE)

September 17, 2007

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000009576

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malnutrition

Clinical Trials on Oral Iron Supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe