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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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.

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.

Detailed Summary:

Subjects (DoD beneficiaries) will be recruited from all non-diabetic female subjects whom are at least 18 years of age and are empanelled for care at Nellis Air Force Base. Upon arrival at the mandatory New Obstetrics (OB) Orientation, potential subjects will be offered an opportunity to participate in this study. A total of 650 subjects will be recruited. After consent and HIPAA Authorization is obtained, the subjects will have Baseline blood pressure, fasting glucose, folic acid, vitamin B12, homocysteine, vitamin D measurements, and weight, height, race, ethnicity, parity, vegetarian status recorded. Subjects will be written a prescription and sent to the Clinical Pharmacy where they will be randomized via block randomization. After randomization, they will receive either placebo or 4 milligrams of folic acid (in addition to the standard of care pre-natal vitamins) from the pharmacy--thus investigators and subjects will be blinded as to their treatment.

Group 1: Placebo plus standard of care pre-natal vitamins (which include 1 milligram of folic acid) a day for the duration of pregnancy Group 2: Will take an additional 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)

The Placebo will be a gelatin capsule filled with starch which does not increase the risks to subjects.

The pre-natal vitamins dispensed at the MOFH Clinical Pharmacy include 1 milligram of folic acid. The folic acid is manufactured by West Ward Pharmaceutical Corp.

Those subjects in Group 2 will be taking a total of 5 milligrams of folic acid (1 milligram of folic acid is contained in their standard of care pre-natal vitamins and they will be given an additional
Sponsor: Mike O'Callaghan Federal Hospital

Current Primary Outcome: Gestational diabetes [ Time Frame: 2 years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Gestational hypertension [ Time Frame: 2 years ]

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.


Original Secondary Outcome: Same as current

Information By: Mike O'Callaghan Federal Hospital

Dates:
Date Received: February 17, 2011
Date Started: April 2012
Date Completion:
Last Updated: November 21, 2013
Last Verified: November 2013