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

The Hospital for Sick Children
Division of GI/Nutrition
555 University Avenue
Toronto
M5G 1X8
Canada

Phone +1 416 813 6171
Email stanley.zlotkin@sickkids.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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) studiedAnaemia
InterventionIngestion (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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Iron and zinc
Primary outcome measureTo determine percent absorption of iron and zinc from micronutrient Sprinkles
Secondary outcome measuresTo examine whether zinc and ascorbic acid have an effect on the absorption of iron from sprinkles.
Overall study start date01/02/2002
Completion date30/09/2002

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit24 Months
SexBoth
Target number of participants88
Key inclusion criteria1. 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 criteria1. Children with symptomatic malaria
2. Children with severe anaemia (Haemoglobin <70 g/l)
Date of first enrolment01/02/2002
Date of final enrolment30/09/2002

Locations

Countries of recruitment

  • Canada
  • India

Study participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

Hospital for Sick Children (Canada)
Not defined

555 University Avenue
Toronto
M5G 1X8
Canada

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan