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 |
| Protocol serial number | 1000005135 |
| Sponsor | Duchesnay Inc (Canada) |
| Funder | Duchesnay Inc |
- 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
Scientific
555 University Ave
Toronto, Ontario
M5G 1X8
Canada
| Phone | +1 416 813 5781 |
|---|---|
| gkoren@sickkids.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy |
| Intervention | A prospective, randomized, open labeled, cross over study of PregVit versus Materna |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | PregVit and Materna |
| Primary outcome measure(s) |
To compare the tolerability and adverse effects of PregVit versus Materna. |
| Key secondary outcome measure(s) |
A comparison of patients’ compliance measured by pill counts of PregVit versus Materna |
| Completion date | 05/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | Pregnant women between 18 and 45 years of age. |
| Key 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 |
| Date of first enrolment | 07/01/2003 |
| Date of final enrolment | 05/05/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
555 University Ave
Toronto, Ontario
M5G 1X8
Canada
M5G 1X8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
