Contact information
Type
Scientific
Primary contact
Dr Gideon Koren
ORCID ID
Contact details
555 University Ave
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 5781
gkoren@sickkids.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1000005135
Study information
Scientific title
A Randomized Cross Over Trial Of Tolerability And Compliance Of A Supplement With Low Iron Separated From Calcium Versus High Iron Combined With Calcium In Pregnant Women
Acronym
Study hypothesis
The lower amounts of iron in PregVit as compared to Materna will result in lower rates of adverse effects (mainly nausea and constipation) among pregnant women
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pregnancy
Intervention
A prospective, randomized, open labeled, cross over study of PregVit versus Materna
Intervention type
Drug
Phase
Not Specified
Drug names
PregVit and Materna
Primary outcome measures
To compare the tolerability and adverse effects of PregVit versus Materna.
Secondary outcome measures
A comparison of patients’ compliance measured by pill counts of PregVit versus Materna
Overall trial start date
07/01/2003
Overall trial end date
05/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women between 18 and 45 years of age.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Pregnant women with insufficient English language skills to understand the questions
2. Pregnant women who refuse to participate in our study
3. Chronic illness
4. Current acute illness and known allergies to either Materna or PregVit
Recruitment start date
07/01/2003
Recruitment end date
05/05/2004
Locations
Countries of recruitment
Canada
Trial participating centre
555 University Ave
Toronto, Ontario
M5G 1X8
Canada
Sponsor information
Organisation
Duchesnay Inc (Canada)
Sponsor details
2925 Industrial blvd
Laval
Quebec
H7L 3W9
Canada
+1 450 668 5200
sgargaun@duchesnay.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Duchesnay Inc
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
2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16595003
Publication citations
-
Results
Ahn E, Pairaudeau N, Pairaudeau N, Cérat Y, Couturier B, Fortier A, Paradis E, Koren G, A randomized cross over trial of tolerability and compliance of a micronutrient supplement with low iron separated from calcium vs high iron combined with calcium in pregnant women [ISRCTN56071145]., BMC Pregnancy Childbirth, 2006, 6, 10, doi: 10.1186/1471-2393-6-10.