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Randomized controlled trial of vitamin D supplement on endothelial function in patients with type 2 diabetes.

Atherosclerosis
March 1, 2013
Yuen-Fung Yiu et al. (12 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

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.

Extracted Claims (13)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AgedBiomarkersBrachial ArteryC-Reactive ProteinCalciumCholecalciferolDiabetes Mellitus, Type 2Double-Blind MethodEndothelium, VascularFemaleHumansMaleMiddle AgedOxidative StressPulse Wave AnalysisVasodilationVitamin D
Study Links
Quality Scores
Safety85
Efficacy30/10
Quality80/10
Citation Metrics
Total Citations139
Citations/Year11.6
Relative Citation Ratio5.36
NIH Percentile93.8%
Research Impact Scores
APT Score0.95
Weight Score1.75
Normalized Score0.62
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