Condition category
Haematological Disorders
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Hospital for Sick Children (Canada)

Sponsor details

555 University Avenue
Toronto
M5G 1X8
Canada

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes