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ID
Source
Brief title
Health condition
Vitamin D deficiency, insulin resistence, non-western immigrants, prevention of type 2 diabetes mellitus .
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the effect of vitamin D supplementation on insulin sensitivity parameters derived from the OGTT in non-western immigrants at risk for diabetes mellitus?
Secondary outcome
1. What is the effect of vitamin D supplementation on glucosemetabolism, BMI, physical performance and lipid profiles in non-western immigrants at risk for diabetes mellitus?
2. What is the compliance with the study medication?
Background summary
In this randomised controlled trial we study the effect of moderately high dose vitamin D supplemtation on insulin sensitivity, glucose metabolism, vascular function and physical performance in non western immigrants at risk for type 2 diabetes mellitus in the Netherlands.
Study objective
A moderately high vitamin D3 supplementation will improve pre-diabetes parameters in non-western immigrants with a vitamin D deficiency and obesity.
Study design
1. 0,2 and 4 months;
2. OGTT;
3. Physical performance test;
4. LASA-score;
5. Vascular functiontest;
6. Bloodtest.
Intervention
4 months vitamin D 1200 IE/calcium 500 mg once daily, vs 4 months placebo/calcium 500 mg once daily.
M.M. Oosterwerff
VU University Medical Center,
Department of Endocrinology/research
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
m.oosterwerff@vumc.nl
M.M. Oosterwerff
VU University Medical Center,
Department of Endocrinology/research
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
m.oosterwerff@vumc.nl
Inclusion criteria
1. Written informed consent;
2. Non-western immigrants, male and female;
3. Aged between 20 and 65 years;
4. A body mass index (BMI) above 27(kg/m2);
5. Vitamin D deficiency and insufficiency;
6. An impaired fasting glucose and/or an impaired random serum glucose;
7. Ability to comply with all study requirements.
Exclusion criteria
1. Pregnant or lactating women, or subjects who intend to become pregnant within the study period;
2. Severe vitamin D deficiency;
3. A history of type 1 diabetes mellitus, secondary diabetes mellitus, acute diabetic complications;
4. Concurrent medication that may interfere with the interpretation of the data of the study;
5. Badly controlled thyroid and/or adrenal disease;
6. Serious physical impairment;
7. Serious diseases;
8. Serious mental impairment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1717 |
| NTR-old | NTR1827 |
| Other | MEC VUMC : 2008/270 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |