Condition category
Pregnancy and Childbirth
Date applied
25/10/2005
Date assigned
01/11/2005
Last edited
10/04/2006
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 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

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

http://www.duchesnay.com

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16595003&query_hl=4&itool=pubmed_DocSum

Publication citations

  1. 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.

Additional files

Editorial Notes