Vitamin D supplementation in Gestational Diabetes Mellitus.

A randomized clinical trial to study the effect of vitamin D supplementation on insulin sensitivity in Gestational Diabetes Mellitus.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27860

Enrollment

Registered

2011-11-21

Start date

2012-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus Insulin resistance Vitamin D deficiency

Interventions

Group1: Cholecalciferol 15.000IU once a week during pregnancy

Group 2: Placebo 15.000IU once a week during pregnancy.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Insulin sensitivity (HOMA-index and β-cell function) measured through fasting insulin and blood glucose levels.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactY.H.M. Poel

Medisch Centrum Alkmaar Wilhelminalaan 12

y.h.m.poel1@mca.nl+31 (0)72 5484444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)