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

June 17, 2020 updated by: Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with vitamin D deficiency
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.
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.
Active Comparator: Patients without vitamin D deficiency
Participants in this group receive only their usual treatments
Drug: Routine treatment
In this group, patients receive their usual medications and treatments

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqiyatallah Medical Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

November 10, 2019

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.BMSU.REC.1392.32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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