Contact information
Type
Scientific
Primary contact
Dr Stanley Howard Zlotkin
ORCID ID
Contact details
The Hospital for Sick Children
Division of GI/Nutrition
555 University Avenue
Toronto
M5G 1X8
Canada
+1 416 813 6171
stanley.zlotkin@sickkids.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-44156
Study information
Scientific title
Acronym
Study hypothesis
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
Hospital for Sick Children (HSC) Research Ethics Board, 20 Jun 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Iron and zinc
Primary outcome measures
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 trial start date
01/02/2002
Overall trial end date
30/09/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
88
Participant exclusion criteria
1. Children with symptomatic malaria
2. Children with severe anaemia (Haemoglobin <70 g/l)
Recruitment start date
01/02/2002
Recruitment end date
30/09/2002
Locations
Countries of recruitment
India
Trial participating centre
The Hospital for Sick Children
Toronto
M5G 1X8
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44156)
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