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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D3
Routine treatment
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mohammad Sadegh Bagheri Baghdasht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with vitamin D deficiency

Patients without vitamin D deficiency

Arm Description

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.

Participants in this group receive only their usual treatments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 17, 2020
Last Updated
June 17, 2020
Sponsor
Baqiyatallah Medical Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04439474
Brief Title
Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
Official Title
Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with vitamin D deficiency
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients without vitamin D deficiency
Arm Type
Active Comparator
Arm Description
Participants in this group receive only their usual treatments
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Routine treatment
Intervention Description
In this group, patients receive their usual medications and treatments
Primary Outcome Measure Information:
Title
Vitamin D serum levels
Description
Vitamin D serum levels measured by blood tests
Time Frame
up to 1 year
Title
Triglyceride
Description
Level of blood triglycerides measured by a blood test
Time Frame
up to 1 year
Title
Blood cholesterol levels
Description
Blood cholesterol levels measured by a blood test
Time Frame
up to 1 year
Title
HDL
Description
Blood HDL levels measured by a blood test
Time Frame
up to 1 year
Title
LDL
Description
Blood LDL levels measured by a blood test
Time Frame
up to 1 year
Title
Fasting blood glucose
Description
Fasting blood glucose levels measured by a blood test
Time Frame
up to 1 year
Title
Neuropathy
Description
Neuropathy based on United Kingdom Screening TEST
Time Frame
up to 1 year
Title
Nephropathy
Description
Nephropathy based on albumin excretion evaluation
Time Frame
up to 1 year
Title
Retinopathy
Description
Retinopathy based on an ophthalmologist's examination
Time Frame
up to 1 year
Title
blood pressure
Description
Systolic and diastolic blood pressure measured by Sphygmomanometer
Time Frame
up to 1 year
Title
HBA1C
Description
Blood sugar levels measured in the last three months measured by blood test
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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