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Optimizing Periconceptional and Prenatal Folic Acid Supplementation

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ClinicalTrials.gov Identifier: NCT02300948
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
Duchesnay Inc.
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children

Brief 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. 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®
  3. 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®.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: PregVit® contains 1.1 mg of folic acid Drug: PregVit-folic 5® contains 5 mg of folic acid Phase 4

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Study Start Date : December 2006
Actual Primary Completion Date : February 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PregVit-Folic 5®-5 mg folic acid
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.
Drug: PregVit-folic 5® contains 5 mg of folic acid
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.
Other Name: PregVit Folic 5®

Active Comparator: PregVit®-1.1 mg folic acid
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.
Drug: PregVit® contains 1.1 mg of folic acid
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.
Other Name: Pregvit®




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300948


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Duchesnay Inc.
Investigators
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Principal Investigator: Gideon Koren, MD The Hospital for Sick Children, Toronto Canada

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Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02300948     History of Changes
Other Study ID Numbers: 1000009554
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Gideon Koren, The Hospital for Sick Children:
Pregnancy
Perinatal Vitamins
folate

Additional relevant MeSH terms:
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Vitamins
Folic Acid
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics