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Vitamin D supplementation in Gestational Diabetes Mellitus.


- candidate number10560
- NTR NumberNTR3158
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2011
- Secondary IDs2011-005209-60 EudraCT
- Public TitleVitamin D supplementation in Gestational Diabetes Mellitus.
- Scientific TitleA randomized clinical trial to study the effect of vitamin D supplementation on insulin sensitivity in Gestational Diabetes Mellitus.
- ACRONYM
- hypothesisVitamin D supplementation will improve glycemic control in patients with gestational diabetes mellitus.
- Healt Condition(s) or Problem(s) studiedVitamin D deficiency, Insulin resistance, Gestational diabetes
- Inclusion criteria1. Written informed consent;
2. Women with gestational diabetes, defined by the WHO criteria:
A. Fasting glucose ≥ 7.0 mmol/l or;
B. Oral glucose tolerance test: 75 g glucose, 2-h glucose ≥ 7.8 mmol/l recognized during pregnancy (WHO criteria).
3. 18-42 years old.
- Exclusion criteria1. Impaired renal function: creatinine * 150 *mol/l or a 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. Vitamin D plasma level ≥ 100 nmol/l or < 15 nmol/l;
6. Hypercalcemia of any reason;
7. Granulomatous diseases influencing vitamin D levels;
8. Urolithiasis;
9. Pre-existent diabetes mellitus of any type;
10. Substance abuse, other than nicotine;
11. Participation in any other trials, involving investigational products within 30 days prior to trial entry;
12. 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 participants64
- InterventionsGroup1: Cholecalciferol 15.000IU once a week during pregnancy;
Group 2: Placebo 15.000IU once a week during pregnancy.
- Primary outcomeInsulin sensitivity (HOMA-index and β-cell function) measured through fasting insulin and blood glucose levels.
- Secondary outcome1. The effect of vitamin D supplementation on serum 25OHD, HbA1c values, bloodpressure, thyroid function, lipid profile and BMI in patients with gestational diabetes mellitus;
2. The effect of vitamin D supplementation on pregnancy characteristics, maternal and neonatal outcomes;
3. Adverse effects.
- TimepointsThe trial starts after the onset of gestational diabetes mellitus.
1. Bloodsamples every 4 weeks;
2. Oral glucose tolerance test;
3. 24-hours bloodpressure measurement;
4. 24-hours glucose measurement;
5. Urine analysis.
- Trial web siteN/A
- statusplanned
- 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 gestational diabetes mellitus in the Netherlands.
- Main changes (audit trail)
- RECORD21-nov-2011 - 28-nov-2011


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