Study protocol: a randomised placebo-controlled clinical trial to s tu dy the effect of vitamin D supplemen tation on gly caemic control in type 2 Diabetes Mellitus SUNNY trial

Krul-Poel, Yvonne H M; Wijland, Hans van; Stam, Frank; Boekel, Edwin ten; Lips, Paul; Şimşek, Suat

doi:10.1186/1472-6823-14-59

Cited by 15 publications

(11 citation statements)

References 33 publications

(27 reference statements)

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“…Several studies indicated that VDD is a very common finding in populations inhabiting northern latitudes [8,9,17]. This deficiency has been observed despite common knowledge about vitamin D sources and its potential food intake.…”

Section: Discussionmentioning

confidence: 99%

Seasonal effect of vitamin D deficiency in patients with acute myocardial infarction

et al. 2016

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A b s t r a c tBackground: Vitamin D is a major regulator of mineral bone metabolism. The lower vitamin D levels in patients with acute myocardial infarction (AMI) and the seasonal variation of vitamin D levels are proposed. Aim:The evaluation of the seasonal relationship of 25(OH)D levels in patients with AMI and analysis of confounding factors (gender or diabetes mellitus) affecting the levels of vitamin D in AMI patients.Methods: Fifty-nine consecutive patients with mean age 58 ± 9.4 years were admitted to the Department of Invasive Cardiology. Subjects had diagnosed uncomplicated myocardial infarction. Blood samples for analysis were collected on patient admission to the cardiac unit after heparin treatment. Samples for routine laboratory tests were immediately processed. For 25(OH)D, the 25-hydroxycholecalciferol test, which measures total vitamin D levels in serum (DRG Instruments GmbH, Marburg, Germany), was applied.Results: Median serum 25(OH)D concentration in AMI patients was below the recommended optimal values 7.1 (2.3-13.3) ng/mL. Fifty-three (89.8%) patients had vitamin D deficiency (VDD) below 20 ng/mL, six (10.2%) patients had suboptimal 25(OH)D levels (between 20 ng/mL and 30 ng/mL), and no one had the recommended reference range. The seasonal effect of 25(OH)D variations among AMI patients was observed with the lowest levels in the beginning of the year (January-March) and the highest levels at the end of the year (September-December) (p = 0.007). Patients with normoglycaemia had significantly higher (9.2 [2.3-16.8] ng/mL) vitamin D levels compared to patients with impaired glucose tolerance (2.3 [2.3-3.9] ng/mL) or diabetes mellitus (8.5 [2.5-13.3] ng/mL) (p = 0.01). Conclusions:A high prevalence of VDD in AMI patients has been confirmed. Supplementation of vitamin D in AMI patients with hyperglycaemia can bring greater benefits.

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Section: Discussionmentioning

confidence: 99%

Seasonal effect of vitamin D deficiency in patients with acute myocardial infarction

et al. 2016

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“…The SUNNY trial (acronym for StUdy the effect of vitamiN D supplemeNtation on glYcaemic control in type 2 DM) is a double-blind randomised placebo-controlled clinical trial, with the primary aim to determine the effect of vitamin D supplementation on glycaemic control in people with type 2 DM (25). Secondary aim was to investigate whether vitamin D supplementation improved the dimensions of HRQOL (25).…”

Section: Methodsmentioning

confidence: 99%

“…Secondary aim was to investigate whether vitamin D supplementation improved the dimensions of HRQOL (25). The trial was conducted in five general practices in and around the city of Alkmaar, the Netherlands, latitude 52°, between July 2012 and April 2013.…”

Section: Methodsmentioning

confidence: 99%

“…A detailed description of the protocol can be found elsewhere (25). Consent of all participants was obtained after full explanation of the purposes and nature of all procedures used in the SUNNY trial.…”

Section: Methodsmentioning

confidence: 99%

“…Change in HRQOL after six months of vitamin D supplementation was one of the secondary outcomes described in the study protocol of the SUNNY trial (25). HRQOL was assessed at baseline and six months after baseline, using the Dutch version of the Short Form 36 (SF-36) Health Survey, which was translated and validated by Aaronson and coworkers in 1994 (26).…”

Section: Methodsmentioning

confidence: 99%

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Effect of vitamin D supplementation on health status in non-vitamin D deficient people with type 2 diabetes mellitus

Westra

Krul-Poel

Wijland

et al. 2016

Endocrine Connections

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ObjectiveIncreased levels of depressive symptoms, fatigue or pain (all dimensions of reduced health-related quality of life (HRQOL)) are common in people with type 2 diabetes mellitus (DM). Earlier studies have reported associations between low vitamin D status and fatigue and depressive symptoms. The aim of the present study was to examine the effects of vitamin D supplementation on dimensions of HRQOL in people with type 2 DM.DesignRandomised, double-blind, placebo-controlled trial.MethodsThe effect of monthly cholecalciferol 50,000 IU vs placebo on HRQOL was assessed in 275 adults with type 2 DM derived from general practices. HRQOL at baseline and after six months using the Short Form 36 Health Survey (SF-36) was collected. Linear regression analyses were used to compare the change in HRQOL over time between the vitamin D and placebo group.Results187/275 (68%) completed baseline and follow-up SF-36 and were included in the analysis. Median serum 25-hydroxyvitamin D almost doubled in the intervention group compared to that in the placebo group (58.5–106.0 nmol/L vs 60.0–61.5 nmol/L, respectively). A small significant difference (adjusted B: −8.90; 95% CI: −17.16 to −0.65) between both groups was seen concerning the SF-36 domain role limitations due to physical problems in disadvantage of the vitamin D group.ConclusionsSix months of vitamin D supplementation did not improve HRQOL in non-vitamin D-deficient people with type 2 DM managed on oral antidiabetic therapy.

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Nutraceuticals in Glucose Balance and Diabetes

Garg¹

2016

Nutraceuticals

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Study protocol: a randomised placebo-controlled clinical trial to s tu dy the effect of vitamin D supplemen tation on gly caemic control in type 2 Diabetes Mellitus SUNNY trial

Cited by 15 publications

References 33 publications

Seasonal effect of vitamin D deficiency in patients with acute myocardial infarction

Seasonal effect of vitamin D deficiency in patients with acute myocardial infarction

Effect of vitamin D supplementation on health status in non-vitamin D deficient people with type 2 diabetes mellitus

Nutraceuticals in Glucose Balance and Diabetes

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