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

Recruiting

• Conditions: Gestational diabetes mellitus; diabetes in pregnancy; 10012653; 10010273

• Registration Number: NL-OMON39103
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Written informed consent
Gestational diabetes, defined by the WHO criteria
women 18-42 years old

Exclusion Criteria

Pre-existent type of diabetes
serum vitamin D <15 nmol/l or >100nmol/l
impaired renal function with an estimated clearance < 50 mmol/l
hypercalciemia
urolithiasis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Insulin sensitivity </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are to examine the predictive value of patient-related<br /><br>factors in terms of changes in serum 25-hydroxyvitamin D (25OHD) and glycemic<br /><br>control. Also the fasting glucose and glucose variation, HbA1c, insulin dose,<br /><br>blood pressure, lipid profile, thyroid function and urine analysis during<br /><br>supplementation of vitamin D in gestational diabetes is assessed. AGE<br /><br>accumulation in the skin. </p><br>