Optimizing periconceptional and prenatal folic acid supplementation
| ISRCTN | ISRCTN50614232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50614232 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/03/2013
- Registration date
- 09/04/2013
- Last edited
- 09/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
We wish to measure red blood cell and serum folate concentrations among women who are healthy and/or childbearing age, those planning a pregnancy or early in pregnancy (< 6 weeks gestation) and who do not practice multivitamin supplementation. We would like to measure and compare folate levels among women before and after implementing multivitamin supplementation with either PregVit® or PregVit-Folic 5®. This may be important information for planning or pregnant women who need folic acid, which has been shown to reduce the risk of neural tube defects and potentially other malformations as well.
Who can participate?
Women who are healthy and/or childbearing age, those planning a pregnancy or early in pregnancy (< 6 weeks gestation) and who do not take vitamin supplements.
What does the study involve?
Participants are randomly allocated to one of two groups: PregVit-Folic 5® (group1) contains 5 mg folic acid or PregVit® (group 2) contains 1.1 mg folic acid. All other vitamin and mineral doses are identical between the 2 supplements. Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation.
The total volume of blood that will be taken is approximately 20 mL (4 teaspoons). Each appointment will be scheduled according to when participants are available. To monitor adherence, the PregVit-Folic 5® blister packs should be returned among with a diary of pill intake (will be provided). To document dietary folate, telephone interviews regarding the diet will be conducted.
What are the possible benefits and risks of participating?
Daily multivitamin supplementation can improve vitamin and mineral concentrations. We will be able to tell participants about folate blood level. Results can be disclosed in person or by mail.
High doses of folic acid can mask vitamin B12 deficiency. However, this is generally not a concern for healthy individuals, with no chronic medical conditions. One study has shown that vitamin B12 deficiency can still be detected even with high folate blood concentrations. PregVit® and PregVit-Folic 5® both contain vitamin B12, thus it is being supplemented. Furthermore, vitamin B12 blood concentrations will be measured alongside folate blood concentrations to monitor for deficiencies.
The needle poking may not be pleasant. We will offer a cream named EMLA® to massage on the arm, which takes away much (sometimes all) of the pain of poking. An alternative that can be used is a gel named Ametop®.
Where is the study run from?
The study took place at The Hospital for Sick Children in Toronto, Canada.
When is the study starting and how long is it expected to run for?
The study started in 2007 and was completed in 2013.
Who is funding the study?
Duchesnay Inc. (Blainville, Quebec, Canada).
Who is the main contact?
Dr. Gideon Koren
gkoren@sickkids.ca
Contact information
Scientific
Hospital for Sick Children
555 University Avenue
Toronto
M5X1X8
Canada
Study information
| Study design | Prospective randomized two-arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | A sample size of 20 women in each arm (N=40) will be sufficient to detect a difference with a power of 85% and alpha of 5% for each part of the study. |
| Scientific title | Optimizing periconceptional and prenatal folic acid supplementation: Red Blood Cell and Serum Folate Levels Achieved with 5 mg versus 1.1 mg Folic Acid in Prenatal Multivitamin-Mineral Supplements |
| Study hypothesis | To assess the serum folate pharmacokinetics of ingesting a single dose of PregVit-Folic5® versus a single dose of PregVit® (a multivitamin containing 1.1 mg folic acid); to assess the steady-state red blood cell (RBC) and serum folate concentrations achieved in non-pregnant, fertile women who supplement daily with PregVit-Folic5® versus PregVit®; and to assess the steady-state RBC and serum folate concentrations achieved before and during pregnancy in women planning a pregnancy or early in pregnancy (<6 weeks gestation) who supplement daily with PregVit-Folic5® versus PregVit®. The Study hypotheses are as follows: 1. The serum folate concentration from ingesting PregVit-folic 5® (5 mg folic acid) will be 4-5 fold larger compared to that of PregVit® (1.1 mg folic acid). 2. Non-pregnant women of childbearing age who supplement daily with PregVit-folic 5® will invariably and optimally achieve and maintain maximum protective blood folate levels (i.e. ≥900 nM red blood cell folate) against NTDs. 3. Women planning a pregnancy or early in pregnancy (<6 weeks gestation) who supplement daily with PregVit-folic 5® will invariably and optimally achieve and maintain maximum protective blood folate levels (i.e. ≥ 900 nM red blood cell folate) against NTDs before and during pregnancy. |
| Ethics approval(s) | The Hospital for Sick Children, March 2007, REB #: 1000009554 |
| Condition | Multivitamin supplementation in pregnancy |
| Intervention | This is a two-arm comparison study: PregVit-Folic 5® (arm 1) contains 5 mg folic acid and PregVit® (arm 2) contains 1.1 mg folic acid. All other vitamin and mineral doses are identical between the 2 supplements. Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation. For the single dose study, only 1 dose was taken. For the multiple dose study, supplementation continued for 30 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure | 1. To assess the serum folate pharmacokinetics in healthy, non-pregnant women of childbearing age who ingest a single evening dose of PregVit-folic 5® (5 mg folic acid) versus a single evening dose of PregVit® (1.1 mg folic acid). 2. To assess steady-state red blood cell and serum folate levels achieved in healthy, non-pregnant women of childbearing age who supplement daily for 30 weeks with PregVit-folic 5® versus PregVit®. 3. To assess the steady-state periconceptional and gestational red blood cell and serum folate levels in women planning a pregnancy or early in pregnancy (<6 weeks gestation) who supplement daily with PregVit-folic 5® versus PregVit®. For the single dose study, extensive blood sampling was conducted over 12 hours. For the multiple dose study, blood sampling was conducted as follows: Return to research site at 6 weeks gestation to draw one blood sample. Pick up next supply of multivitamins (hospital pharmacy). Return to research site at 12 weeks gestation to draw one blood sample. Pick up next supply of multivitamins (hospital pharmacy). Return to research site at 30 weeks gestation to draw last blood sample. |
| Secondary outcome measures | To assess adherence and tolerability of the prenatal mutlivitamins |
| Overall study start date | 01/03/2007 |
| Overall study end date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 40 |
| Participant inclusion criteria | Women planning a pregnancy, or women less than 6 weeks pregnant who are not using a prenatal mutlivitamin |
| Participant exclusion criteria | 1. Women who are already taking a prenatal multivitamin. 2. Women who are allergic to any of the ingredients in PregVit or PregVit Folic 5. 3. Women with iron disorders. |
| Recruitment start date | 01/03/2007 |
| Recruitment end date | 01/07/2013 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5X1X8
Canada
Sponsor information
Industry
950 Boul Michele-Bohec
Blainville
J7C5E2
Canada
| Website | http://www.duchesnay.com |
|---|---|
"ROR" |
https://ror.org/03v67de52 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
