Optimizing Periconceptional and Prenatal Folic Acid Supplementation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02300948
• Date of registration: 21/11/2014
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Optimizing Periconceptional and Prenatal Folic Acid Supplementation
• Scientific title: Optimizing Periconceptional and Prenatal Folic Acid Supplementation
• Date of first enrolment: December 2006
• Target sample size: 83
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02300948
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Gideon Koren, MD
• Affiliation: The Hospital for Sick Children, Toronto Canada

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

Intervention(s)

Drug: PregVit-folic 5® contains 5 mg of folic acid

Drug: PregVit® contains 1.1 mg of folic acid

Primary Outcome(s)

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]

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 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]

Secondary ID(s)

1000009554

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duchesnay Inc.