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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Routine treatment; Drug: Vitamin D3

• Registration Number: NCT04439474
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Primary Completion: 2019-11-10
• Study Completion: 2020-02-10
• Status Verified: 2020-06
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Last Update Submitted: 2020-06-17
• Study First Posted: 2020-06-19
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without vitamin D deficiency	Routine treatment	Participants in this group receive only their usual treatments
Patients with vitamin D deficiency	Vitamin D3	This group receives 50,000 units of vitamin D3 daily for up to 8 days until the serum level of vitamin D reaches above 30 ng/ml.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mohammad Sadegh Bagheri Baghdasht; 🇮🇷 Tehran, Iran, Islamic Republic of