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

ISRCTN ISRCTN56071145
DOI https://doi.org/10.1186/ISRCTN56071145
Secondary identifying numbers 1000005135
Submission date
25/10/2005
Registration date
01/11/2005
Last edited
03/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gideon Koren
Scientific

555 University Ave
Toronto, Ontario
M5G 1X8
Canada

Phone +1 416 813 5781
Email gkoren@sickkids.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA 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
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy
InterventionA prospective, randomized, open labeled, cross over study of PregVit versus Materna
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)PregVit and Materna
Primary outcome measureTo compare the tolerability and adverse effects of PregVit versus Materna.
Secondary outcome measuresA comparison of patients’ compliance measured by pill counts of PregVit versus Materna
Overall study start date07/01/2003
Completion date05/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants100
Key inclusion criteriaPregnant women between 18 and 45 years of age.
Key exclusion criteria1. 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
Date of first enrolment07/01/2003
Date of final enrolment05/05/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

555 University Ave
Toronto, Ontario
M5G 1X8
Canada

Sponsor information

Duchesnay Inc (Canada)
Industry

2925 Industrial blvd
Laval, Quebec
H7L 3W9
Canada

Phone +1 450 668 5200
Email sgargaun@duchesnay.com
Website http://www.duchesnay.com
ROR logo "ROR" https://ror.org/03v67de52

Funders

Funder type

Industry

Duchesnay Inc

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/04/2006 Yes No

Editorial Notes

03/10/2017: internal review.