NCT00213161

Brief Summary

The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

First QC Date

September 13, 2005

Last Update Submit

April 14, 2021

Conditions

Anemia

Keywords

anemiairon deficiencyiron dropsiron supplementmalnutritionpediatrics

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing

Secondary Outcomes (4)

  • Ferritin at 8 weeks

  • Serum Transferrin Receptor (sTfR) at 8 weeks

  • side effects every 2 weeks

  • compliance with iron supplement assessed every 2 weeks

Interventions

iron supplement, iron dropsDRUG

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months of age
  • anemic (Hb 70-100g/L)
  • ingesting weaning food in addition to breast milk
  • free from major illness (including symptomatic for malaria) and afebrile
  • living within study area for the next two months
  • parental consent obtained
  • only one child per household in the study

You may not qualify if:

  • Hb \< 70 or ≥ 100 g/L
  • Not receiving any complementary foods
  • Receiving an iron supplement within two weeks of the date of enrolment
  • chronic illness
  • severely malnourished: weight for age z-score \< -3.0
  • another child in the household is a subject in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Memorial Hospital (KEM)

Pune, Maharashtra, India

Location

MeSH Terms

Conditions

AnemiaIron DeficienciesMalnutrition

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNutrition Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Stanley Zlotkin, PhD, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
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, 2005

First Posted

September 21, 2005

Study Start

August 1, 2004

Study Completion

June 1, 2005

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations

IN(1)