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The Effect of High Dose Folic Acid Versus Placebo on the Rate of Gestational Diabetes or Gestational Hypertension in Pregnant Women

NCT01302756 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-11-25

No results posted yet for this study

Summary

The purpose of this study is to determine if higher-than usual doses of daily folic acid has an effect on the rate of gestational diabetes mellitus (GDM) or gestational hypertension in pregnant women while determining status of folic acid, vitamin B12, homocysteine and vitamin D in pregnancy.

Conditions

  • Gestational Diabetes
  • Gestational Hypertension

Interventions

OTHER

Placebo

Group 1: Placebo plus standard of care pre-natal vitamins (which include 1 milligram of folic acid) a day for the duration of pregnancy

DIETARY_SUPPLEMENT

Folic Acid

Group 2: 4-milligrams of folic acid a day for the duration of pregnancy plus standard of care pre-natal vitamins (which include 1 milligram of folic acid)

Sponsors & Collaborators

  • Mike O'Callaghan Military Hospital

    lead FED

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-08-31
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302756 on ClinicalTrials.gov