search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effect of vitamin D-supplementation on glucose metabolism in non-western immigrants in the Netherlands.


- candidate number5793
- NTR NumberNTR1827
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mei-2009
- Secondary IDs2008/270 MEC VUMC
- Public TitleThe effect of vitamin D-supplementation on glucose metabolism in non-western immigrants in the Netherlands.
- Scientific TitleThe effect of vitamin D-supplementation on insulin sensitivity in non-western immigrants in the Netherlands.
- ACRONYMVitamin D-supplementation and insulin sensitivity in non-western immigrants
- hypothesisA moderately high vitamin D3 supplementation will improve pre-diabetes parameters in non-western immigrants with a vitamin D deficiency and obesity.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Vitamin D deficiency, Prevention, Insulin resistance
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-jan-2011
- Target number of participants128
- Interventions4 months vitamin D 1200 IE/calcium 500 mg once daily, vs 4 months placebo/calcium 500 mg once daily.
- Primary outcomeWhat 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 outcome1. 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?
- Timepoints1. 0,2 and 4 months;
2. OGTT;
3. Physical performance test;
4. LASA-score;
5. Vascular functiontest;
6. Bloodtest.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.M. Oosterwerff
- CONTACT for SCIENTIFIC QUERIESdr. E.M.W. Eekhoff
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD20-mei-2009 - 30-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl