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Vitamin D supplementation in type 2 Diabetes Mellitus.


- candidate number10548
- NTR NumberNTR3154
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2011
- Secondary IDs2011-005209-60 EudraCT
- Public TitleVitamin D supplementation in type 2 Diabetes Mellitus.
- Scientific TitleA randomized clinical trial to study the effect of vitamin D supplementation on glycemic control in type 2 Diabetes Mellitus.
- ACRONYM
- hypothesisVitamin D supplementation will improve glycemic control in patients with type 2 diabetes melliuts.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Vitamin D deficiency, Insulin resistance
- Inclusion criteria1. Written informed consent;
2. Patients with T2DM treated with lifestyle advises whether or not in combination with metformin;
3. Adults (≥ 18 years);
4. HbA1c values between 7.0 - 8.5% for the last 3 months.
- Exclusion criteria1. Impaired renal function: creatinine * 150 *mol/l or an estimated creatinin clearance < 50 ml/min, to the discretion of the investigator;
2. Cardiac problems:
A. Decompensated heart failure (NYHA III and IV);
B. Diagnosis of unstable angina pectoris;
C. Myocardial infarction within the last 12 months.
3. Mental retardation, or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past;
4. Insufficient knowledge of the Dutch language;
5. Serum 25OHD < 15 nmol/l or > 150 nmol/l;
6. Hypercalcemia of any reason;
7. Urolithiasis;
8. Granulomatous diseases influencing vitamin D levels;
9. Diabetes mellitus other than type 2;
10. Recent or current use of insulin or incretin mimetics;
11. Using other oral antidiabetics than metformin;
12. Pregnancy and/or lactation;
13. Substance abuse, other than nicotine;
14. Participation in any other trials, involving investigational products within 30 days prior to trial entry;
15. Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate1-jul-2014
- Target number of participants300
- InterventionsGroup1: Cholecalciferol 50.000IU once a month during 6 months;
Group 2: Placebo 50.000IU once a month during 6 months.
- Primary outcomeHbA 1c values.
- Secondary outcome1. The effect of vitamin D supplementation on serum 25OHD, insulin sensitivity, bloodpressure, thyroid function, lipid profile and BMI in patients with type 2 diabets melltius;
2. Adverse effects.
- TimepointsBlood samples, urine analysis and physical examination will be drawn at 0, 3 and 6 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Y.H.M. Poel
- CONTACT for SCIENTIFIC QUERIESDr. S. Simsek
- Sponsor/Initiator Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Alkmaar
- PublicationsN/A
- Brief summaryIn this randomized placebo controlled trial we want to examine the effect of vitamin D supplementation on glycemic control in patients with type 2 diabetes mellitus in the Netherlands.
- Main changes (audit trail)
- RECORD17-nov-2011 - 2-dec-2013


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