NCT00530374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

September 13, 2007

Last Update Submit

April 14, 2021

Conditions

MalnutritionIron Deficiency

Keywords

PediatricsMalnutritionIron DeficiencySprinklesOral Iron Supplementation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Each child in this group will receive daily supplementation of Iron Sprinkles with a single sachet for 60 days

Dietary Supplement: Oral Iron Supplement

2

PLACEBO COMPARATOR

Each child in this group will receive daily supplementation of placebo Sprinkles with a single sachet for 60 days

Dietary Supplement: Placebo

Interventions

Oral Iron SupplementDIETARY_SUPPLEMENT

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

Also known as: Sprinkles
1
PlaceboDIETARY_SUPPLEMENT

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

Also known as: Placebo Sprinkles
2

Eligibility Criteria

Age1 Year - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • chronic illness other than malnutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Village of Shombhuganj

Shombhuganj, Mymensingh District, Bangladesh

Location

Related Publications (1)

  • Lemaire M, Islam QS, Shen H, Khan MA, Parveen M, Abedin F, Haseen F, Hyder Z, Cook RJ, Zlotkin SH. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr. 2011 Aug;94(2):585-93. doi: 10.3945/ajcn.110.009316. Epub 2011 Jun 29.

    PMID: 21715512DERIVED

MeSH Terms

Conditions

MalnutritionIron Deficiencies

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesIron Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Stanley Zlotkin, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Global Child Health

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations

BA(1)