Optimizing Periconceptional and Prenatal Folic Acid Supplementation

NCT02300948 | Completed Phase 4 DMC

• 1 other identifier: 1000009554
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

There are three objectives in this study:

1. 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. 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. 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®.

Conditions

Pregnancy

Keywords

Pregnancy; Perinatal Vitamins; folate

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 days

Study Arms (2)

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.

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.

Drug: PregVit® contains 1.1 mg of folic acid

Interventions

PregVit® contains 1.1 mg of folic acid 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.

Also known as: Pregvit®

PregVit®-1.1 mg folic acid

PregVit-folic 5® contains 5 mg of folic acid 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.

Also known as: PregVit Folic 5®

PregVit-Folic 5®-5 mg folic acid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Duchesnay Inc.: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gideon Koren, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

CA (1)