Optimizing periconceptional and prenatal folic acid supplementation

Optimizing periconceptional and prenatal folic acid supplementation: Red Blood Cell and Serum Folate Levels Achieved with 5 mg versus 1.1 mg Folic Acid in Prenatal Multivitamin-Mineral Supplements

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50614232

Enrollment

Registered

2013-04-09

Start date

2007-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multivitamin supplementation in pregnancy Pregnancy and Childbirth Multivitamin supplementation in pregnancy

Interventions

This is a two-arm comparison study: PregVit-Folic 5® (arm 1) contains 5 mg folic acid and PregVit® (arm 2) contains 1.1 mg folic acid. All other vitamin and mineral doses are identical between the 2 s

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women planning a pregnancy, or women less than 6 weeks pregnant who are not using a prenatal mutlivitamin

Exclusion criteria

Exclusion criteria: 1. Women who are already taking a prenatal multivitamin. 2. Women who are allergic to any of the ingredients in PregVit or PregVit Folic 5. 3. Women with iron disorders.

Design outcomes

Primary

Measure	Time frame
1. To assess 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). 2. To assess 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®. 3. To assess 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 single dose study, extensive blood sampling was conducted over 12 hours. For the multiple dose study, blood sampling was conducted as follows: 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.	—

Measure

Time frame

1. To assess 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). 2. To assess 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®. 3. To assess 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 single dose study, extensive blood sampling was conducted over 12 hours. For the multiple dose study, blood sampling was conducted as follows: 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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Secondary

Measure	Time frame
To assess adherence and tolerability of the prenatal mutlivitamins	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026