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A prospective randomized controlled trial of the effects of vitamin D supplementation on long-term glycemic control in type 2 diabetes mellitus of Korea.

Endocrine journal
January 1, 2014
Ohk-Hyun Ryu et al. (6 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the glucose-lowering effect of vitamin D combined with calcium in Korean T2DM subjects with vitamin D deficiency.

Results Summary

Vitamin D supplementation (with calcium) significantly increased vitamin D levels and reduced PTH levels but had no effect on HbA1c or HOMA-IR, indicating no improvement in glycemic control. The study confirmed the safety of the supplementation regimen.

Population

Korean T2DM patients with stable glycemic control (HbA1c <8.5%) and vitamin D levels <20 ng/mL.

Effective Dosage

100 mg of elemental calcium administered twice daily.

Duration

24 weeks.

Interactions

None mentioned.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
vitamin D supplementation
no change
long-term glycemic control
T2DM patients
no significant change
had no effect
#1
vitamin D supplementation
increase
vitamin D levels
T2DM patients
15.6 ± 7.1 ng/mL vs 30.2 ± 10.8 ng/mL
were significant differences
#2
vitamin D supplementation
decrease
PTH levels
T2DM patients
1.4 ± 15.3 pg/mL vs -5.5 ± 9.8 pg/mL
change
#3
vitamin D supplementation
no change
HbA1c
T2DM patients
7.27 ± 0.87% vs 7.40 ± 0.90%
were no differences
#4
vitamin D supplementation
no change
HOMA-IR
T2DM patients
-
were no differences
#5
vitamin D supplementation
no change
serum calcium and kidney function
T2DM patients
-
showed
#6
vitamin D supplementation
increase
attainment of vitamin D sufficiency
T2DM patients
-
is safe and effective
#7
Abstract

Epidemiologic studies have shown that low vitamin D levels are associated with reduced insulin sensitivity and increased risk of developing type 2 diabetes mellitus (T2DM). However, there is little evidence that vitamin D supplementation improves glucose intolerance. We evaluated the glucose-lowering effect of vitamin D in Korean T2DM subjects. We enrolled 158 T2DM patients who had stable glycemic control [hemoglobin A1c (HbA1c) <8.5%] and vitamin D levels less than 20 ng/mL. The participants were randomized into two groups: Placebo (100 mg daily of elemental calcium administered twice a day) or Vitamin D (1000 IU daily of cholecalciferol combined with 100 mg of elemental calcium administered twice a day). We compared outdoor physical activity, glycemic control, homeostasis model of assessment - insulin resistance (HOMA-IR), and parathyroid hormone (PTH), during the 24-week intervention. We analyzed the data of 129 participants (placebo =65, vitamin D =64) who completely followed the protocol. Outdoor physical activity and oral anti-diabetic drugs did not differ between the groups. While there were significant differences in the vitamin D levels (15.6 ± 7.1 ng/mL vs 30.2 ± 10.8 ng/mL, P<0.001) and change in PTH levels (1.4 ± 15.3 pg/mL vs -5.5 ± 9.8 pg/mL, P=0.003) between the placebo and vitamin D groups, there were no differences in HbA1c (7.27 ± 0.87% vs 7.40 ± 0.90%) (P=0.415) and HOMA-IR. Serum calcium and kidney function results showed that the vitamin D supplementation was safe. While vitamin D supplementation is safe and effective in the attainment of vitamin D sufficiency, it had no effect on long-term glycemic control for T2DM in our study.

Medical Subject Headings (MeSH)
AdultAgedBlood GlucoseCalciumCalcium, DietaryCholecalciferolDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansInsulin ResistanceMaleMiddle AgedParathyroid HormoneRepublic of KoreaVitamin D Deficiency
Study Links
Quality Scores
Safety90
Efficacy30/10
Quality80/10
Citation Metrics
Total Citations48
Citations/Year4.4
Relative Citation Ratio2.21
NIH Percentile77.4%
Research Impact Scores
APT Score0.95
Weight Score1.73
Normalized Score0.64
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