Vitamin D and Type 2 Diabetes Study

Completed · Not applicable · Has a placebo group

Conditions studied: Prediabetes, Type 2 Diabetes

In brief

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

Key facts

Study ID

NCT01942694

Run by

Tufts Medical Center

People needed

2423

Starts

2013-10-01

Expected to finish

2018-11-01

Last updated by the study team

2022-08-16

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:
• Fasting plasma glucose (FPG) 100-125 mg/dL
• 2-hour plasma glucose (2hPG) 140-199 mg/dL
• Hemoglobin A1c (HbA1c) 5.7-6.4%
• Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
• Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
• Provision of signed and dated written informed consent prior to any study procedures.
• Major Exclusion Criteria:
• Diabetes based on either of the following criteria:
• History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
• Meeting the diagnosis criteria for diabetes
• History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
• Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
• Currently breastfeeding.

Where it is running

• Southwest American Indian Center — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Orlando VA Medical Center — Orlando, Florida, United States
• Florida Hospital Translational Research Institute — Orlando, Florida, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Tulane University Health Sciences — New Orleans, Louisiana, United States
• Maine Medical Center — Scarborough, Maine, United States
• MedStar Community Clinical Research Center — Hyattsville, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Health Partners Riverside Clinic — Minneapolis, Minnesota, United States
• Omaha VA Medical Center — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Beth Israel Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Kaiser Permanente Center for Health Research — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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