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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Gestational diabetes
研究概览
简要总结
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.
详细描述
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 4 milligrams of folic acid as part of this research study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- •Pregnant females (DoD beneficiaries) at least 18 years of age
排除标准
- •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
结局指标
主要结局
Gestational diabetes
时间窗: 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.
次要结局
- Gestational hypertension(2 years)