PregnancyPhase 4NCT02300948
Optimizing Periconceptional and Prenatal Folic Acid Supplementation
A Phase 4 study testing PregVit® contains 1.1 mg of folic acid and PregVit-folic 5® contains 5 mg of folic acid in people with Pregnancy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
There are three objectives in this study: 1. 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) 2. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- PregVit® contains 1.1 mg of folic acid and PregVit-folic 5® contains 5 mg of folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any healthy, non-pregnant, fertile woman between 18 and 45 years of age.(Part 1 and 2)
- Have not taken multivitamins or folic acid supplements in the past 6 months. (Part 1 and 2)
- Healthy women between 18 to 45 years of age.(For Part 3)
- Planning a pregnancy, or within the first 2 weeks of missing a menstrual period, or within the first 6 weeks of pregnancy.(Part 3)
- Have not taken multivitamins or folic acid supplements in the past 6 months.(Part 3)
Who cannot join
- Have hypersensitivities to the ingredients in PregVit-folic 5® or PregVit®. (Part 1, 2 and 3)
- Have chronic medical conditions (i.e. hypertension, diabetes, epilepsy, irritable bowel syndrome, hypo/hyper-thyroidism, depression). (Part 1, 2 and 3)
- Chronic use (i.e. long-term, specifically prescribed dose) of oral medications (i.e. oral contraceptives, anticonvulsants, antibiotics, antidepressants).(Part 1, 2 and 3)
- Have a family history or previous pregnancy affected by NTDs.(Part 1, 2 and 3)
- Do not agree to the protocol.(Part 1, 2 and 3)
Trial locations and contacts
1 site in 1 country.
About this study
There are three objectives in this study:
- 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®
- 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®.
Read the detailed description
A prospective, randomized, 2-arm, interventional study involving women of child-bearing age will compare the folate status and pharmacokinetics of PregVit-Folic5® and PregVit®.
Some women of childbearing age, particularly those who do not practice multivitamin supplementation, may have inadequate intake and blood concentrations of vitamins and minerals, including those micronutrients which are important in pregnancy. Folic acid is one of the important vitamins in pregnancy which can be obtained from folate-rich foods, folic acid-fortified foods, and multivitamins. It is important to examine the folate status of fertile women, who do not usually practice multivitamin supplementation, before and after they implement folic acid containing-multivitamin supplementation.
The investigators 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. The investigators 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.
The Study hypotheses are as follows:
- 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).
- 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.
- 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.
- Conditions
- Pregnancy
- Being tested
- PregVit® contains 1.1 mg of folic acid, PregVit-folic 5® contains 5 mg of folic acid
- Keywords
- Pregnancy, Perinatal Vitamins, folate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregVit® contains 1.1 mg of folic acidDrug
Also called Pregvit®
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.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.
PregVit-folic 5® contains 5 mg of folic acidDrug
Also called PregVit Folic 5®
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.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.
| Study group | Role | What they receive |
|---|---|---|
| PregVit-Folic 5®-5 mg folic acid | Experimental | Prenatal multivitamin-mineral supplement called PregVit-folic 5® contains 5 mg of folic acid. All other vitamin and mineral doses are identical between the 2 supplements, except for folic acid. 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. Receives: Drug: PregVit-folic 5® contains 5 mg of folic acid |
| PregVit®-1.1 mg folic acid | Active comparator | Prenatal multivitamin-mineral supplement called PregVit® contains 1.1 mg of folic acid. All other vitamin and mineral doses are identical between the 2 supplements, except for folic acid. 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. Receives: Drug: PregVit® contains 1.1 mg of folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
For the single dose study, extensive blood sampling was conducted over 12 hours.
Measured: 1 day
The 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®.
The first clinic visit will be to draw blood (5 mL) to measure baseline red blood cell folate, plasma folate, and vitamin B12 concentrations (after a 6 hour fast). Then blood samples will be drawn at weeks 2, 4, and 6 of study participation to measure RBC and plasma folate levels to determine what peak level is achieved and the time required to achieve the peak (or achieve RBC folate concentration of 900 nM or greater). As supplementation continues, RBC and plasma folate levels will be measured again at 12 and 30 weeks of participation.
Measured: 6 days
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 multiple dose study, blood sampling was conducted as follows:
The first clinic visit will be to draw blood (5 mL) to measure baseline red blood cell folate, plasma folate, and vitamin B12 concentrations (after a 6 hour fast). 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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2006
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Duchesnay Inc.
- Responsible party
- Principal investigator, Gideon Koren, The Hospital for Sick Children
- Investigators
- Gideon Koren, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300948
- Sponsor's protocol ID
- 1000009554
- Status last verified
- Nov 2014
- First submitted
- 21 Nov 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Periconceptional and Prenatal Folic Acid Supplementation
- ClinicalTrials.gov ID
- NCT02300948
- Acronym / sponsor ID
- 1000009554
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Perinatal Vitamins, folate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Duchesnay Inc.
- Study start
- Dec 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are three objectives in this study:
- 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®
- 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®.
Detailed description
A prospective, randomized, 2-arm, interventional study involving women of child-bearing age will compare the folate status and pharmacokinetics of PregVit-Folic5® and PregVit®.
Some women of childbearing age, particularly those who do not practice multivitamin supplementation, may have inadequate intake and blood concentrations of vitamins and minerals, including those micronutrients which are important in pregnancy. Folic acid is one of the important vitamins in pregnancy which can be obtained from folate-rich foods, folic acid-fortified foods, and multivitamins. It is important to examine the folate status of fertile women, who do not usually practice multivitamin supplementation, before and after they implement folic acid containing-multivitamin supplementation.
The investigators 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. The investigators 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.
The Study hypotheses are as follows:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PregVit-Folic 5®-5 mg folic acid | Experimental | Drug: PregVit-folic 5® contains 5 mg of folic acidPrenatal multivitamin-mineral supplement called PregVit-folic 5® contains 5 mg of folic acid. All other vitamin and mineral doses are identical between the 2 supplements, except for folic acid. 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. |
| PregVit®-1.1 mg folic acid | Active comparator | Drug: PregVit® contains 1.1 mg of folic acidPrenatal multivitamin-mineral supplement called PregVit® contains 1.1 mg of folic acid. All other vitamin and mineral doses are identical between the 2 supplements, except for folic acid. 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Any healthy, non-pregnant, fertile woman between 18 and 45 years of age.(Part 1 and 2)
- Have not taken multivitamins or folic acid supplements in the past 6 months. (Part 1 and 2)
- Healthy women between 18 to 45 years of age.(For Part 3)
- Planning a pregnancy, or within the first 2 weeks of missing a menstrual period, or within the first 6 weeks of pregnancy.(Part 3)
- Have not taken multivitamins or folic acid supplements in the past 6 months.(Part 3)
Key exclusion criteria (5 listed)
- Have hypersensitivities to the ingredients in PregVit-folic 5® or PregVit®. (Part 1, 2 and 3)
- Have chronic medical conditions (i.e. hypertension, diabetes, epilepsy, irritable bowel syndrome, hypo/hyper-thyroidism, depression). (Part 1, 2 and 3)
- Chronic use (i.e. long-term, specifically prescribed dose) of oral medications (i.e. oral contraceptives, anticonvulsants, antibiotics, antidepressants).(Part 1, 2 and 3)
- Have a family history or previous pregnancy affected by NTDs.(Part 1, 2 and 3)
- Do not agree to the protocol.(Part 1, 2 and 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregVit® contains 1.1 mg of folic acidAlso: Pregvit®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.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. | Drug | PregVit®-1.1 mg folic acid |
| PregVit-folic 5® contains 5 mg of folic acidAlso: PregVit Folic 5®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.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. | Drug | PregVit-Folic 5®-5 mg folic acid |
Primary outcome
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).
Time frame: 1 day
For the single dose study, extensive blood sampling was conducted over 12 hours.
The 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®.
Time frame: 6 days
The first clinic visit will be to draw blood (5 mL) to measure baseline red blood cell folate, plasma folate, and vitamin B12 concentrations (after a 6 hour fast). Then blood samples will be drawn at weeks 2, 4, and 6 of study participation to measure RBC and plasma folate levels to determine what peak level is achieved and the time required to achieve the peak (or achieve RBC folate concentration of 900 nM or greater). As supplementation continues, RBC and plasma folate levels will be measured again at 12 and 30 weeks of participation.
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®.
Time frame: 4 days
For the multiple dose study, blood sampling was conducted as follows: The first clinic visit will be to draw blood (5 mL) to measure baseline red blood cell folate, plasma folate, and vitamin B12 concentrations (after a 6 hour fast). 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Koren, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PregVit® contains 1.1 mg of folic acid and PregVit-folic 5® contains 5 mg of folic acid in people with Pregnancy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.