Optimizing Periconceptional and Prenatal Folic Acid Supplementation

NCT ID: NCT02300948

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2013-04-30

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®.

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PregVit-folic 5® contains 5 mg of folic acid

Intervention Type: DRUG

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®-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.

Group Type: ACTIVE_COMPARATOR

PregVit® contains 1.1 mg of folic acid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pregvit®; PregVit Folic 5®

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duchesnay Inc.

INDUSTRY

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Gideon Koren

Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gideon Koren, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000009554

Identifier Type: -

Identifier Source: org_study_id