N/A
Completed N=2,423
Vitamin D and Type 2 Diabetes Study
Source: ClinicalTrials.gov NCT01942694 ↗Enrolled (actual)
2,423
Serious AEs
13.5%
Results posted
Sep 2020
Primary outcomePrimary: Time to Development of Diabetes — 323; 293 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Development of Diabetes |
323; 293 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration |
— | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation) |
806; 810; 315; 301; 91; 100 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria) |
429; 427; 783; 784 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI |
429; 435; 783; 776 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference |
585; 620; 627; 591 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age |
103; 106; 439; 468; 670; 637 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure) |
898; 892; 314; 319 | — |
| SECONDARY Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements |
793; 826; 419; 385 | — |
| SECONDARY Blood Plasma 25OHD Concentration. |
— | — |
| SECONDARY Number of Participants With Adverse Events. |
— | — |
| SECONDARY Change in Blood Pressure as a Continuous Variable. |
— | — |
| SECONDARY Number of Participants Who Discontinue Study Pills. |
— | — |
| SECONDARY Change in FPG as a Continuous Variable. |
— | — |
| SECONDARY Change in 2hPG as a Continuous Variable. |
— | — |
| SECONDARY Change in HbA1c as a Continuous Variable. |
— | — |
| SECONDARY Measurement of Insulin Resistance (Derived From the OGTT). |
— | — |
| SECONDARY Measurement of Beta Cell Secretion (Derived From the OGTT) |
— | — |
| SECONDARY Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration. |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01942694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.