a study to evaluate the role of vitamin-D supllementation in teatment of patints with type 2 diabetes

A Randomized, two arm, single centre study to assess the effect of Vitamin D supplementation on glycemic control in type 2 diabetes patients who are not well controlled on current treatment and who are vitamin D deficient.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/10/003059

Enrollment

110

Registered

2012-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients diagnosed of type 2 diabetes and who are vitamin-D defecient

Interventions

Intervention1: 60000 IU of vitamin D granules + glimepiride + metformin: Treatment will be initiated at a dose of 60000 IU of vitamin D granules per week (8 sachets) for 8 weeks and subsequently a dos

Eligibility

Inclusion criteria

Inclusion criteria: 1.Men and women >18 years of age, upper limit at the discretion of Investigator 2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus at least 6 months prior to screening 3.Patients with HBA1c >7.5% and 4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed

Exclusion criteria

Exclusion criteria: 1.Type-1 diabetes mellitus 2.Pregnant & lactating patients 3.Patients who have hypersensitivity to vitamin D granules. 4.Patients with renal calculi. 5.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months 6.Cardiac status New York Heart Association (NYHA) III-IV 7.Impaired renal function as shown by, but not limited to, serum creatinine >= 1.5 mg/dL for males, or >= 1.4 mg/dL for females 8.Subject with anticipated need of surgery within study period. 9.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ 10.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years 11.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 12.Any other condition according to investigator

Design outcomes

Primary

Measure	Time frame
â?¢ Effect of Vitamin D supplementation on HbA1C, FPG and PPG in type 2 diabetic patientsTimepoint: Baseline, Day 30, Day 60 and Day 90	—

Secondary

Measure	Time frame
â?¢ Efficacy of Vitamin D supplementation in raising 25 (OH) D levels in deficient type 2 diabetes patientsTimepoint: Baseline, Day 30 , Day 60 and Day 90	—

Countries

India

Contacts

Public ContactMrManoj Prabhu

Abbott Healthcare Pvt Ltd

manoj.naik@abbott.in022-39536910

Outcome results

None listed

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