N/A
N=125
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Vitamin D Deficiency · Insulin Resistance · Type 2 Diabetes Mellitus · Cardiovascular Disease · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00736632 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP) — 126.6; 131.1; 79.2; 78.9 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP) |
126.6; 131.1; 79.2; 78.9; 127.6; 133.2 | — |
| SECONDARY Brachial Artery Reactivity Testing |
7.8; 8.6; 8.5; 7.5; 7.8; 7.8 | — |
| SECONDARY Macrophage Cholesterol Metabolism |
1.01; 0.47 | — |
| SECONDARY Serum Calcium |
9.1; 9.1; 9.2; 9.1; 9.1; 9.3 | — |
| SECONDARY HbA1C |
7.0; 7.0; 7.4; 6.9; 7.4; 7.0 | — |
| SECONDARY Vitamin D |
46.1; 40.1; 37.7; 40.7; 44.5; 42.7 | — |
| SECONDARY hsCRP |
3.7; 6.0; 3.6; 5.9; 4.2; 6.7 | — |
| SECONDARY Fasting Glucose |
126.7; 123.3; 137.4; 124.9; 138.4; 128.7 | — |
| SECONDARY Urine Calcium to Creatinine Ratio. |
69.8; 88.1; 102.3; 114.1; 89.9; 134.5 | — |
Summary
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- 25 (OH) vitamin D levels 160 or diastolic >100 mmHg
- High urine calcium or history of recurrent kidney stones
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
Data sourced from ClinicalTrials.gov (NCT00736632). 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.