Iron and zinc absorption in anaemic infants
| ISRCTN | ISRCTN92162678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92162678 |
| Secondary identifying numbers | MCT-44156 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 18/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stanley Howard Zlotkin
Scientific
Scientific
The Hospital for Sick Children
Division of GI/Nutrition
555 University Avenue
Toronto
M5G 1X8
Canada
| Phone | +1 416 813 6171 |
|---|---|
| stanley.zlotkin@sickkids.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. To measure the absorption of two different doses of iron from Sprinkles when added to a cereal-based complementary food provided to anaemic and non-anaemic infants (Study I) 2. To determine whether there is a difference in the absorption of zinc at two different zinc doses and a constant iron dose (Study II) 3. To examine whether zinc and ascorbic acid have an effect on the absorption of iron from Sprinkles (Study III) |
| Ethics approval(s) | Hospital for Sick Children (HSC) Research Ethics Board, 20 Jun 2001 |
| Health condition(s) or problem(s) studied | Anaemia |
| Intervention | Ingestion (with a cereal-based weaning food) of micronutrient Sprinkles containing intrinsically labeled iron and/or zinc (stable isotopes) with added vitamin A and ascorbic acid. Group 1: 30 mg elemental iron, 5 mg zinc and 50 mg ascorbic acid Group 2: 30 mg elemental iron, 10 mg zinc and 50 mg ascorbic acid Group 3 with 30 mg elemental iron, 5 mg zinc and no ascorbic acid All groups also contained 300 µg RE of retinol acetate vitamin A. Trial details received: 12 Sept 2005 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Iron and zinc |
| Primary outcome measure | To determine percent absorption of iron and zinc from micronutrient Sprinkles |
| Secondary outcome measures | To examine whether zinc and ascorbic acid have an effect on the absorption of iron from sprinkles. |
| Overall study start date | 01/02/2002 |
| Completion date | 30/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 88 |
| Key inclusion criteria | 1. 6-24 months of age, either sex 2. Ingesting weaning foods in addition to breast milk 3. Free from major illness (including malaria) 4. Afebrile 5. Haemoglobin ≥70 g/l 6. Parental consent obtained |
| Key exclusion criteria | 1. Children with symptomatic malaria 2. Children with severe anaemia (Haemoglobin <70 g/l) |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 30/09/2002 |
Locations
Countries of recruitment
- Canada
- India
Study participating centre
The Hospital for Sick Children
Toronto
M5G 1X8
Canada
M5G 1X8
Canada
Sponsor information
Hospital for Sick Children (Canada)
Not defined
Not defined
555 University Avenue
Toronto
M5G 1X8
Canada
"ROR" |
https://ror.org/057q4rt57 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44156)
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 |
