Status:
COMPLETED
Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Duchesnay Inc.
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 ...
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 childbea...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT02300948
Start Date
December 1 2006
End Date
April 1 2013
Last Update
November 25 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8