Effect of Vitamin D
Supplementation on Glycemic
Control in Patients With Type 2
Diabetes (SUNNY Trial): A
Randomized Placebo-Controlled
Trial
Diabetes Care 2015;38:1420–1426 | DOI: 10.2337/dc15-0323
OBJECTIVE
Low vitamin D status has been associated with impaired glycemic control in
patients with type 2 diabetes. The purpose of our study was to evaluate the ef-
fect of vitamin D supplementation on glycemic control in patients with type 2
diabetes.
RESEARCH DESIGN AND METHODS
This randomized, double-blind, placebo-controlled trial was conducted in 275
adult patients with type 2 diabetes without insulin treatment. Patients were
randomly assigned to receive either vitamin D
3
(50,000 IU/month) or placebo
for 6 months. To assess the primary outcome of the study, change in HbA
1c
, we
performed a linear regression analysis.
RESULTS
Mean baseline serum 25-hydroxyvitamin D [25(OH)D] increased from 60.6 6 23.3 to
101.4 6 27.6 nmol/L and 59.1 6 23.2 to 59.8 6 23.2 nmol/L in the vitamin D and
placebo group, respectively. Mean baseline HbA
1c
was 6.8 6 0.5% (51 6 6 mmol/mol)
in both groups. After 6 months, no effect was seen on HbA
1c
(mean difference: b = 0.4
[95% CI 20.6 to 1.5]; P = 0.42) and other indicators of glycemic control (HOMA of insulin
resistance, fasting insulin, and glucose) in the entire study population. Subgroup anal-
ysis in patients with a serum 25(OH)D <50 nmol/L or an HbA
1c
level >7% (53 mmol/mol)
did not differ the results.
CONCLUSIONS
In a well-controlled group of patients with type 2 diabetes, intermittent high-dose
vitamin D supplementation did not improve glycemic control.
Type 2 diabetes, characterized by peripheral insulin resistance and pancreatic b-cell
dysfunction, represents a worldwide epidemic with significant comorbidity and
mortality due to microvascular and macrovascular complications (1). Although
therapies for type 2 diabetes have improved over the last few decades, new insights
for the prevention and management of type 2 diabetes remain necessary due to the
increased prevalence of the disease.
1
Department of Internal Medicine, Medical Cen-
ter Alkmaar, Alkmaar, the Netherlands
2
Department of Clinical Chemistry, Medical Cen-
ter Alkmaar, Alkmaar, the Netherlands
3
Amsterdam Rheumatology and Immunology
Center, VU University Medical Center, Amsterdam,
the Netherlands
4
Department of Epidemiology and Biostatistics,
EMGO Institute for Health and Care Research,
VU University Medical Center, Amsterdam, the
Netherlands
5
Department of General Practice, DIAZON,
Alkmaar, the Netherlands
6
Department of Internal Medicine/Endocrinology,
VU University Medical Center, Amsterdam, the
Netherlands
Corresponding author: Suat Simsek, s.simsek@
mca.nl.
Received 13 February 2015 and accepted 22 April
2015.
Clinical trial reg. no. NTR3154, www.trialregister.nl.
© 2015 by the American Diabetes Association.
Readers may use this article as long as the work
is properly cited, the use is educational and not
for profit, and the work is not altered.
Yvonne H.M. Krul-Poel,
1
Sanne Westra,
1
Edwin ten Boekel,
2
Marieke M. ter Wee,
3
Natasja M. van Schoor,
4
Hans van Wijland,
5
Frank Stam,
1
Paul T.A.M. Lips,
6
and Suat Simsek
1,6
1420 Diabetes Care Volume 38, August 2015
CLIN CARE/EDUCATION/NUTRITION/PSYCHOSOCIAL