High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-06-30

Brief Summary

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Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.

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Detailed Description

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Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.

Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

4000 IU vitamin D3 +prenatal vitamin

Group Type EXPERIMENTAL

4000 IU vitamin D3

Intervention Type DRUG

vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Control

standard prenatal vitamin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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4000 IU vitamin D3

vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Intervention Type DRUG

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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Inclusion Criteria

1. Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers
2. Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
3. Subject possesses as least one of the following characteristics:

1. BMI greater than or equal to 30 kg/m2
2. History of gestational diabetes in a prior pregnancy
3. History of infant with birth weight of 4500g or greater
4. Subject is capable of giving informed consent

Exclusion Criteria

1. Age less than 18 years
2. Multiple gestation pregnancies (twins, triplets or greater multiples)
3. Vitamin D deficiency (defined as less than 20 ng/mL)
4. Preexisting diabetes mellitus defined as either:

1. pre-existing diagnosis prior to current pregnancy
2. failure of three-hour glucose tolerance test in first trimester of pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No