Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439474
• Other study ID #: IR.BMSU.REC.1392.32
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: June 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. One group included participants with vitamin D deficiency and the other group did not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 10, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes

• Having conscious satisfaction

Exclusion Criteria:

• Patients with a history of gastrointestinal surgery

• Patients with a history of renal failure

• Patients with a history of vitamin D intake and calcium-containing compounds

• Patients with a history of liver disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias

Intervention

Drug:
• Vitamin D3
For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml.
• Routine treatment
In this group, patients receive their usual medications and treatments

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D serum levels	Vitamin D serum levels measured by blood tests	up to 1 year
Primary	Triglyceride	Level of blood triglycerides measured by a blood test	up to 1 year
Primary	Blood cholesterol levels	Blood cholesterol levels measured by a blood test	up to 1 year
Primary	HDL	Blood HDL levels measured by a blood test	up to 1 year
Primary	LDL	Blood LDL levels measured by a blood test	up to 1 year
Primary	Fasting blood glucose	Fasting blood glucose levels measured by a blood test	up to 1 year
Primary	Neuropathy	Neuropathy based on United Kingdom Screening TEST	up to 1 year
Primary	Nephropathy	Nephropathy based on albumin excretion evaluation	up to 1 year
Primary	Retinopathy	Retinopathy based on an ophthalmologist's examination	up to 1 year
Primary	blood pressure	Systolic and diastolic blood pressure measured by Sphygmomanometer	up to 1 year
Primary	HBA1C	Blood sugar levels measured in the last three months measured by blood test	up to 1 year