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

NCT03037593 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 1611M98781
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes

Keywords

Pregnancy; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• incidence of gestational diabetes

  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.

  Baseline to Delivery of child

Secondary Outcomes (5)

• Prescription for insulin or oral hypoglycemic agents

  Baseline to Delivery of child

• Mode of delivery

  Delivery of child

• Birth weight

  Delivery of Child

• Apgar score

  Birth of child to 5 minutes

• Shoulder Dystocia

  Birth of child

Study Arms (2)

Intervention

EXPERIMENTAL

4000 IU vitamin D3 +prenatal vitamin

Drug: 4000 IU vitamin D3

Control

NO INTERVENTION

standard prenatal vitamin

Interventions

4000 IU vitamin D3 DRUG

vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Also known as: cholecalciferol

Intervention

Eligibility Criteria

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

You may qualify if:

• 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
• Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
• Subject possesses as least one of the following characteristics:
• BMI greater than or equal to 30 kg/m2
• History of gestational diabetes in a prior pregnancy
• History of infant with birth weight of 4500g or greater
• Subject is capable of giving informed consent

You may not qualify if:

• Age less than 18 years
• Multiple gestation pregnancies (twins, triplets or greater multiples)
• Vitamin D deficiency (defined as less than 20 ng/mL)
• Preexisting diabetes mellitus defined as either:
• pre-existing diagnosis prior to current pregnancy
• failure of three-hour glucose tolerance test in first trimester of pregnancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Cholecalciferol

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Samantha Hoffman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)