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The effect of vitamin D on metabolic disorders in diabetic patients

The effect of vitamin D supplementation on metabolic, oxidant, inflammatory indices, sirtuin-1 and irisin in type 2 diabetic patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201604202365N11
Enrollment
90
Registered
2016-08-21
Start date
2016-08-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

diabetes mellitus type2. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: pearl of VitaminD3 50000IU weekly for 8 weeks. Intervention 2: Placebo of edible paraffin and similar to vitaminD3.
Prevention
Placebo
pearl of VitaminD3 50000IU weekly for 8 weeks

Sponsors

International vice Chancellor for research of Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sirtuin-1. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory Kit.;Irisin. 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.;HbA1C. Timepoint: Before and 8 weeks after intervention. Method of measurement: Laboratory Kit.

Secondary

MeasureTime frame
C reactive peptide. Timepoint: Before and 8 weeks after intervention. Method of measurement: laboratory Kit.;Oxidant indices. Timepoint: Before and 8 weeks after intervention. Method of measurement: laboratory Kit.;25 hydroxyvitaminD3. 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.;Lipid profile. Timepoint: Before and 8 weeks after intervention. Method of measurement: laboratory Kit.;Inflammatory indices. Timepoint: Before and 8 weeks after intervention. Method of measurement: laboratory Kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Vafa

Iran University of Medical Sciences

Rezavafa@yahoo.com; Rezavafa@iums.ac.ir0088779118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 19, 2026