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

NCT01302756 | Withdrawn

• 1 other identifier: FWH20110006H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

gestational diabetes; gestational hypertension; folic acid

Outcome Measures

Primary Outcomes (1)

• Gestational diabetes

  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.

  2 years

Secondary Outcomes (1)

• Gestational hypertension

  2 years

Interventions

Placebo OTHER

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

Folic Acid DIETARY_SUPPLEMENT

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 24, 2011
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11