Condition category
Haematological Disorders
Date applied
12/09/2005
Date assigned
21/12/2007
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stanley Zlotkin

ORCID ID

Contact details

The Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada
stanley.zlotkin@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00213161

Protocol/serial number

GLH-63082

Study information

Scientific title

Establishing an iron supplementation strategy to reduce the prevalence of iron deficiency anaemia among infants and young children in India

Acronym

Study hypothesis

The response to a 14.25 mg iron dose from drops will be greater than the response to a similar iron dose from Sprinkles, and will be equivalent to either a 20 or 30 mg iron dose from Sprinkles (either as encapsulated ferrous fumarate or micronized ferric pyrophosphate).

Ethics approval

1. Research Ethics Board of the Hospital for Sick Children, Toronto, Ontario (Canada) approved on the 16th February 2004 (ref: 0019970046)
2. Indian Council of Medical Research, New Delhi (India) approved on the 6th May 2004 (ref: IND/FRC/442/2004-IHD)

Study design

Single centre, interventional, 5 arms, randomised cluster trial with study participant, study investigator, caregiver, outcome assessor, and data analyst blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Anaemia

Intervention

Three different doses of Sprinkles: 12.5 mg, 20 mg, and 30 mg of elemental iron, and two forms of iron (encapsulated ferrous fumarate and micronized ferric pyrophosphate) compared to the standard and recommended dose of iron drops in India (Fersoft drops -14.25 mg Fe), daily for 2 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Sprinkles (encapsulated ferrous fumarate and micronized ferric pyrophosphate), Fersoft drops

Primary outcome measures

Haemoglobin, measured at 4 weeks, 8 weeks, 8 months after first dosing.

Secondary outcome measures

1. Serum ferritin, measured at 8 weeks
2. Side effects, measured every 2 weeks

Overall trial start date

01/08/2004

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 6 - 18 months of age, either sex
2. Anaemic (haemoglobin [Hb] 70 - 100 g/L)
3. Ingesting weaning food in addition to breast milk
4. Free from major illness (including symptomatic for malaria) and afebrile
5. Living within study area for the following two months
6. Parental consent obtained
7. Only one child per household in the study

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

425

Participant exclusion criteria

1. Hb less than 70 or greater than or equal to 100 g/L
2. Not receiving any complementary foods
3. Receiving an iron supplement within two weeks of the date of enrolment
4. Chronic illness
5. Severely malnourished: weight for age z-score less than -3.0
6. Another child in the household is a subject in this study

Recruitment start date

01/08/2004

Recruitment end date

01/12/2005

Locations

Countries of recruitment

India

Trial participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

Organisation

Research Institute Hospital for Sick Children (Canada)

Sponsor details

555 University Avenue
Toronto
M5G 1X8
Canada
stanley.zlotkin@sickkids.ca

Sponsor type

Research organisation

Website

http://www.sickkids.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: GLH-63082)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17351300

Publication citations

  1. Results

    Hirve S, Bhave S, Bavdekar A, Naik S, Pandit A, Schauer C, Christofides A, Hyder Z, Zlotkin S, Low dose 'Sprinkles'-- an innovative approach to treat iron deficiency anemia in infants and young children., Indian Pediatr, 2007, 44, 2, 91-100.

Additional files

Editorial Notes