'Sprinkles': a new approach to reduce anaemia among children in India

ISRCTN ISRCTN26272961
DOI https://doi.org/10.1186/ISRCTN26272961
ClinicalTrials.gov (NCT) NCT00213161
Protocol serial number GLH-63082
Sponsor Research Institute Hospital for Sick Children (Canada)
Funder Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: GLH-63082)
Submission date
12/09/2005
Registration date
21/12/2007
Last edited
25/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stanley Zlotkin
Scientific

The Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada

stanley.zlotkin@sickkids.ca

Study information

Primary study designInterventional
Study designSingle centre, interventional, 5 arms, randomised cluster trial with study participant, study investigator, caregiver, outcome assessor, and data analyst blinded
Secondary study designRandomised controlled trial
Scientific titleEstablishing an iron supplementation strategy to reduce the prevalence of iron deficiency anaemia among infants and young children in India
Study objectivesThe 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(s)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)
Health condition(s) or problem(s) studiedAnaemia
InterventionThree 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sprinkles (encapsulated ferrous fumarate and micronized ferric pyrophosphate), Fersoft drops
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit18 Months
SexAll
Target sample size at registration425
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2004
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • Canada
  • India

Study participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2007 Yes No
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