The effects of vitamin D supplementation on glycemic control and oxidative stress parameters in patients with type 2 diabetes mellitus

The effects of vitamin D supplementation on insulin resistance, Castelli Risk Index I and TG/ TBARS Index in patients with type 2 diabetes: a 6-month follow-up randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25609316

Enrollment

130

Registered

2019-12-02

Start date

2018-05-03

Completion date

Unknown

Last updated

2023-01-30

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

The eligible participants recruited consecutively were randomly assigned to two groups in 1:1 ratio. The serum level of 25(OH)D (marker of vitamin D status) was measured at baseline in all participant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diabetes mellitus type 2 2. = 30 years of age 3. Good metabolic control (HbA1c = 7 %) 4. Treated with metformin and lifestyle advice

Exclusion criteria

Exclusion criteria: 1. Use of vitamin D supplements and any diabetes pharmacotherapy other than metformin 2. Use of drugs which affect the metabolism of vitamin D (corticosteroids and anticonvulsants) 3. Severe anemia 4. Chronic liver or kidney failure 5. Alcoholism 6. Pregnancy 7. Malabsorption 8. Urolithiasis 9. Hypercalcemia 10. Body mass index (BMI) = 40 kg/m2 11. Presence of acute or chronic inflammatory conditions

Design outcomes

Primary

Measure	Time frame
1. Glycemic control measured through assessing blood levels of glycated hemoglobin (HbA1c) immunoturbidimetrically at baseline, 3 months and 6 months. 2. Insulin resistance measured using levels of HOMA-IR (the homeostasis model assessment of insulin resistance calculated by the formula: HOMA-IR=Fasting Blood Glucose (mmol/L)×Fasting Insulin (µIU/L)/22.5) at baseline, 3 months and 6 months	—

Secondary

Measure	Time frame
1. Atherogenic risk index is determined through the total cholesterol/HDL cholesterol ratio (Castelli risk I) at baseline, 3 months and 6 months 2. Oxidative stress is measured in plasma through markers of: 2.1. Lipid peroxidation measured in plasma and expressed as the Thiobarbituric acid-reactive substances (TBARS) biomarker malondyadehide (MDA) at baseline, 3 months and 6 months 2.2. Advanced oxidation protein product level (AOPP) measured in plasma spectrophotometrically, expressed as chloramine-T equivalents at baseline, 3 months and 6 months	—

Measure

Time frame

1. Atherogenic risk index is determined through the total cholesterol/HDL cholesterol ratio (Castelli risk I) at baseline, 3 months and 6 months 2. Oxidative stress is measured in plasma through markers of: 2.1. Lipid peroxidation measured in plasma and expressed as the Thiobarbituric acid-reactive substances (TBARS) biomarker malondyadehide (MDA) at baseline, 3 months and 6 months 2.2. Advanced oxidation protein product level (AOPP) measured in plasma spectrophotometrically, expressed as chloramine-T equivalents at baseline, 3 months and 6 months

—

Countries

Montenegro

Contacts

Public ContactMilena Cojic

milenac@ac.me+382 (0)69160909

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026