Phase 3
Completed N=127
Vitamin D for Established Type 2 Diabetes (DDM2)
Source: ClinicalTrials.gov NCT01736865 ↗Enrolled (actual)
127
Serious AEs
10.2%
Results posted
Jan 2019
Primary outcomePrimary: Disposition Index — 0.023; 0.149 index
◆ Published Evidence
Established
97citations · ~10 / year
Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation.
Summary
This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).
Linked Publications (3)
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Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation.
-
Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes.
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Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disposition Index |
0.023; 0.149 | — |
| SECONDARY Number of Participants With Change in Glycemia |
53; 52 | — |
Eligibility Criteria
Inclusion Criteria
- Established type 2 diabetes, defined by one of the following two criteria:
- Age ≥ 25 years and ≤ 75 years
- BMI: 23 to 40 kg/m2 inclusive
- Provision of signed and dated written informed consent prior to any study procedures.
Major Exclusion Criteria
- "Severe" diabetes defined by one of the following criteria:
- - (a) Symptoms of hyperglycemia;
- - (b) Screening HbA1c ≥ 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy]
- History of nephrolithiasis or hypercalcemia
Data sourced from ClinicalTrials.gov (NCT01736865) and the linked publication. 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.