'Sprinkles': a new approach to reduce anaemia among children in India
| ISRCTN | ISRCTN26272961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26272961 |
| ClinicalTrials.gov number | NCT00213161 |
| Secondary identifying numbers | 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
Scientific
The Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada
| stanley.zlotkin@sickkids.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Establishing an iron supplementation strategy to reduce the prevalence of iron deficiency anaemia among infants and young children in India |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sprinkles (encapsulated ferrous fumarate and micronized ferric pyrophosphate), Fersoft drops |
| Primary outcome measure | 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 study start date | 01/08/2004 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 18 Months |
| Sex | Both |
| Target number of participants | 425 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Canada
- India
Study participating centre
The Hospital for Sick Children
Toronto
M5G 1X8
Canada
M5G 1X8
Canada
Sponsor information
Research Institute Hospital for Sick Children (Canada)
Research organisation
Research organisation
555 University Avenue
Toronto
M5G 1X8
Canada
| stanley.zlotkin@sickkids.ca | |
| Website | http://www.sickkids.ca/ |
"ROR" |
https://ror.org/057q4rt57 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: GLH-63082)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
