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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39103

Enrollment

Registered

2012-04-17

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Gestational diabetes mellitus

Interventions

Follow-up: onset of GDM till the end of pregnancy Group 1: Cholecalciferol 15.000IU once a week Group 2: Placebol 15.000IU once a week

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Pre-existent type of diabetes serum vitamin D 100nmol/l impaired renal function with an estimated clearance

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)