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The effect of vitamin D3 in the treatment of diabetes

Phase 3
Conditions
diabetes mellitus type2.
Non-insulin-dependent diabetes mellitus
Registration Number
IRCT201605112365N12
Lead Sponsor
Vice Chancellor for research of Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Diabetes type2 in both sexes; 25 to 65 years; Serum 25 hydroxy vitaminD3 levels less than 30 nano grams per milliliter (ng/ml); Body mass index (BMI) between 25 to 35 kilograms per square meter (kg/m²); glycated hemoglobin (HbA1c) level less than 8.5%; Willingness to participate in the project
Exclusion criteria: Insulin consumption; Smoking or drinking alcohol at least once a week; Regular consumption of (at least once a week) herbal, antioxidant, multivitamin mineral, vitaminD3 and omega3 supplements; Taking birth control pills and Nonsteroidal antiiflammatory drugs (NSAIDs) in the last three months; Pregnancy and lactatin; Diagnosed diseases such as cancer, digestive diseases, liver and kidney diseases, autoimmune diseases, inflammation, hypothyroidism, polycystic ovarian syndrome; Changing usual and balanced diet with vegetarian diets or single product or any other unusual changes in the last three months; triglyceride levels more than 250 Milligrams per deciliter (mg/dl) and cholesterol more than 300 mg/dl; Exposure to sun and use of solarium for tanning up to 3 months before the start of the study; Taking medications affecting vitaminD3 metabolism such as Antiepileptic drugs and corticosteroids; Consuming less than 90% of supplements; Suffering from any acute illness; Any change in the type and amount of blood glucose lowering drugs

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
HbA1c. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory kit.;Fasting blood sugar. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory kit.;Lipid profile. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory kit.;Blood pressur. Timepoint: Before and 8 weeks after intervention. Method of measurement: Barometer.;Liver indices. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory kit.;Kidney indices. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory kit.
Secondary Outcome Measures
NameTimeMethod
Serum 25(OH)D3 Level. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory Kit.;Fasting Insulin. Timepoint: Before and 8 weeks after intervention. Method of measurement: laboratory Kit.;Insulin resistance. Timepoint: Before and 8 weeks after intervention. Method of measurement: HOMA-IR formula.
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