Vitamin D deficiency, insulin resistence, non-western immigrants, prevention of type 2 diabetes mellitus .
Conditions
Interventions
4 months vitamin D 1200 IE/calcium 500 mg once daily, vs 4 months placebo/calcium 500 mg once daily.
Sponsors
VUmc (funding ZonMw)
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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? | — |
Contacts
Public ContactM.M. Oosterwerff
Postbus 7057
Outcome results
None listed