Vitamin D supplementation will improve glycemic control in patients with type 2 diabetes melliuts.
ID
Bron
Aandoening
Type 2 diabetes mellitus
Insulin resistance
Vitamin D deficiency
Ondersteuning
Medisch Centrum Alkmaar
Interne geneeskunde
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
HbA 1c values.
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Vitamin D supplementation will improve glycemic control in patients with type 2 diabetes melliuts.
Onderzoeksopzet
Blood samples, urine analysis and physical examination will be drawn at 0, 3 and 6 months.
Onderzoeksproduct en/of interventie
Group1: Cholecalciferol 50.000IU once a month during 6 months;
Group 2: Placebo 50.000IU once a month during 6 months.
Publiek
Wilhelminalaan 12
Y.H.M. Poel
Alkmaar 1815 JD
The Netherlands
+31 (0)72 5484444
y.h.m.poel1@mca.nl
Wetenschappelijk
Wilhelminalaan 12
Y.H.M. Poel
Alkmaar 1815 JD
The Netherlands
+31 (0)72 5484444
y.h.m.poel1@mca.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3006 |
NTR-old | NTR3154 |
Ander register | EudraCT : 2011-005209-60 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |