Randomized controlled trial of vitamin D supplement on endothelial function in patients with type 2 diabetes.
Study Goal
The researchers aimed to investigate the effect of vitamin D supplementation (which influences calcium metabolism) on endothelial function in patients with type 2 diabetes mellitus.
Results Summary
Vitamin D supplementation increased serum ionized calcium levels but did not improve vascular function, inflammation, or oxidative stress markers in type 2 DM patients.
Population
100 patients with type 2 diabetes mellitus.
Effective Dosage
5000 IU/day of vitamin D (indirectly affecting calcium levels).
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
vitamin D supplementation | increase | serum 25-hydroxyvitamin D [25(OH)D] concentration | type 2 DM patients | treatment effect 34.7 ng/mL, 95% CI 26.4-42.9 | had significant increases | #1 |
vitamin D supplementation | increase | serum ionized calcium | type 2 DM patients | treatment effect 0.037 mmol/L, 95% CI 0.007-0.067 | had significant increases | #2 |
vitamin D supplementation | decrease | serum parathyroid hormone concentration | type 2 DM patients | treatment effect -0.55 pmol/L, 95% CI -1.08 to -0.02 | decreased | #3 |
vitamin D supplementation | no change | vascular function as determined by FMD | type 2 DM patients | - | did not improve | #4 |
vitamin D supplementation | no change | circulating EPC count | type 2 DM patients | - | did not improve | #5 |
vitamin D supplementation | no change | baPWV | type 2 DM patients | - | did not improve | #6 |
vitamin D supplementation | no change | hsCRP | type 2 DM patients | - | were also similar | #7 |
vitamin D supplementation | no change | oxidative stress markers | type 2 DM patients | - | were also similar | #8 |
vitamin D supplementation | no change | low- and high-density lipoprotein | type 2 DM patients | - | were also similar | #9 |
vitamin D supplementation | no change | glycated hemoglobin | type 2 DM patients | - | were also similar | #10 |
12 weeks oral supplementation of vitamin D | no change | vascular function | patients with type 2 DM | - | did not significantly affect | #11 |
12 weeks oral supplementation of vitamin D | no change | serum biomarkers of inflammation | patients with type 2 DM | - | did not significantly affect | #12 |
12 weeks oral supplementation of vitamin D | no change | oxidative stress | patients with type 2 DM | - | did not significantly affect | #13 |
BACKGROUND: Suboptimal vitamin D status is associated with endothelial dysfunction and an increased risk of cardiovascular diseases but it is unclear whether vitamin D supplementation is beneficial. The aim was to investigate the effect of vitamin D supplementation on endothelial function in patients with type 2 diabetes mellitus (DM). METHODS: In a double-blind, placebo-controlled trial, we randomized 100 type 2 DM patients to vitamin D supplement (5000 IU/day, n = 50) or placebo (controls, n = 50) for 12 weeks. Assessment of vascular function with brachial artery flow-mediated dilatation (FMD), circulating levels of endothelial progenitor cells (EPCs) and brachial-ankle pulse wave velocity, and metabolic parameter, high-sensitivity C-reactive protein (hsCRP) and oxidative stress markers were performed before and after the supplementation. RESULTS: After 12 weeks, vitamin D treated patients had significant increases in serum 25-hydroxyvitamin D [25(OH)D] concentration (treatment effect 34.7 ng/mL, 95% CI 26.4-42.9, P < 0.001) and serum ionized calcium (treatment effect 0.037 mmol/L, 95% CI 0.007-0.067, P = 0.018); decreased serum parathyroid hormone concentration (treatment effect -0.55 pmol/L, 95% CI -1.08 to -0.02, P = 0.042) compared to patients who received placebo. Nevertheless, vitamin D supplementation did not improve vascular function as determined by FMD, circulating EPC count or baPWV (all P > 0.05). Furthermore, hsCRP, oxidative stress markers, low- and high-density lipoprotein and glycated hemoglobin were also similar between two groups (all P > 0.05). CONCLUSION: In patients with type 2 DM, 12 weeks oral supplementation of vitamin D did not significantly affect vascular function or serum biomarkers of inflammation and oxidative stress. CLINICAL TRIAL NUMBER: HKCTR-867, www.hkclinicaltrials.com.