Effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in gestational diabetes mellitus

Phase 3

Conditions: Gestational Diabetes Mellitus.
Diabetes Mellitus
E10-E14

Registration Number: IRCT20150607022585N3

Lead Sponsor: Bandare-abbas University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Pregnant women diagnosed with gestational diabetes at the age of 18-40 years.
Pregnant women diagnosed with gestational diabetes who had not a previous history of overt diabetes.
Pregnant women diagnosed with gestational diabetes who do not receive vitamin D supplement.
Pregnant women diagnosed with gestational diabetes who do not smoke or do not use any drugs
Pregnant women with gestational diabetes who do not have any systemic diseases including liver disease, hypertension, hypothyroidism.
Pregnant women diagnosed with gestational diabetes who do not have multiple pregnancies
Pregnant women diagnosed with gestational diabetes who do not take any medication which affect glucose metabolism like steroids and insulin
Pregnant women diagnosed with gestational diabetes who do not take and medication any glucose lowering drugs.

Exclusion Criteria

unwillingness of participants to continue the study
Start of insulin therapy during intervention
miscarriage

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose. Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: commercial kit, enzymatic method.;??????? ???. Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: immunoassay (Elisa) kit.;Insulin resistance index (HOMA-IR). Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: using formula.

Secondary Outcome Measures

Name	Time	Method
HDL-C. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit.;Serum vitamin D concentration. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit.;Serum calcium. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit.;Serum phosphorus. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit.;Serum triglyceride. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit.;Serum total cholesterol. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit.;LDL-C. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit.