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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

This study is not yet open for participant recruitment.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302756
First received: February 17, 2011
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Gestational Diabetes
Gestational Hypertension
 Other: Placebo
Dietary Supplement: Folic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of High Dose Folic Acid Versus Placebo on the Rate of Gestational Diabetes or Gestational Hypertension in Pregnant Women: a Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Gestational diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Subjects will have baseline blood levels drawn for fasting glucose, folic acid, vitamin B12, homocysteine and vitamin D measurements. They will be randomized to take either standard of care dose of folic acid or an additional 4 milligrams of folic acid for the duration of their pregnancy. The blood levels will again be drawn for fasting glucose, folic acid, vitamin B12, homocysteine and vitamin D measurements.


Secondary Outcome Measures:
  • Gestational hypertension [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Subjects will have baseline blood levels drawn for fasting glucose, folic acid, vitamin B12, homocysteine and vitamin D measurements. They will be randomized to take either standard of care dose of folic acid or an additional 4 milligrams of folic acid for the duration of their pregnancy. The blood levels will again be drawn for fasting glucose, folic acid, vitamin B12, homocysteine and vitamin D measurements.


Estimated Enrollment: 650
Study Start Date: April 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • Pregnant females (DoD beneficiaries) at least 18 years of age

Exclusion Criteria:

  • Diagnosed as being diabetic
  • Diagnosed with chronic hypertension prior to pregnancy
  • Personal or family history of neural tube defects or personal history of birth defects
  • Unable to communicate
  • Non-English speaking
  • Patients who know they will move prior to delivery
  • Patients who have had Gastric Bypass surgery
  • Patients with known seizure disorder or on anti-seizure medication
  • Patients taking a folic acid antagonist
  • Patients who are hypohomocysteine
  • Previously diagnosed with Methylenetetrahydrofolate reductase (MTHFR) mutation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302756

Contacts
Contact: Jill Teixeira, MBA/HCM, CCRP, CCRC 7026532756 jill.teixeira@nellis.af.mil
Contact: Paul Crawford, M.D. 7026532970 paul.crawford@nellis.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital Not yet recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Jill M Teixeira, MBA/HCM,CCRP, CCRC     7026532756     jill.teixeira@nellis.af.mil    
Sub-Investigator: Matthew Snyder, D.O.            
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302756     History of Changes
Other Study ID Numbers: FWH20110006H
Study First Received: February 17, 2011
Last Updated: April 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Mike O'Callaghan Federal Hospital:
gestational diabetes
gestational hypertension
folic acid

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
 Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013