No registrations found.
ID
Source
Health condition
Gestational diabetes mellitus
Insulin resistance
Vitamin D deficiency
Sponsors and support
Medisch Centrum Alkmaar
Interne geneeskunde
Intervention
Outcome measures
Primary outcome
Insulin sensitivity (HOMA-index and β-cell function) measured through fasting insulin and blood glucose levels.
Secondary outcome
1. 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.
Background summary
In 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.
Study objective
Vitamin D supplementation will improve glycemic control in patients with gestational diabetes mellitus.
Study design
The 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.
Intervention
Group1: Cholecalciferol 15.000IU once a week during pregnancy;
Group 2: Placebo 15.000IU once a week during pregnancy.
Wilhelminalaan 12
Y.H.M. Poel
Alkmaar 1815 JD
The Netherlands
+31 (0)72 5484444
y.h.m.poel1@mca.nl
Wilhelminalaan 12
Y.H.M. Poel
Alkmaar 1815 JD
The Netherlands
+31 (0)72 5484444
y.h.m.poel1@mca.nl
Inclusion criteria
1. 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 criteria
1. 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.
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 | NL3010 |
| NTR-old | NTR3158 |
| Other | EudraCT : 2011-005209-60 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |