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

NCT04439474 | Completed DMC

• 1 other identifier: IR.BMSU.REC.1392.32
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (11)

• Vitamin D serum levels

  Vitamin D serum levels measured by blood tests

  up to 1 year

• Triglyceride

  Level of blood triglycerides measured by a blood test

  up to 1 year

• Blood cholesterol levels

  Blood cholesterol levels measured by a blood test

  up to 1 year

• HDL

  Blood HDL levels measured by a blood test

  up to 1 year

• LDL

  Blood LDL levels measured by a blood test

  up to 1 year

• Fasting blood glucose

  Fasting blood glucose levels measured by a blood test

  up to 1 year

• Neuropathy

  Neuropathy based on United Kingdom Screening TEST

  up to 1 year

• Nephropathy

  Nephropathy based on albumin excretion evaluation

  up to 1 year

• Retinopathy

  Retinopathy based on an ophthalmologist's examination

  up to 1 year

• blood pressure

  Systolic and diastolic blood pressure measured by Sphygmomanometer

  up to 1 year

• HBA1C

  Blood sugar levels measured in the last three months measured by blood test

  up to 1 year

Study Arms (2)

Patients with vitamin D deficiency

EXPERIMENTAL

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

Patients without vitamin D deficiency

ACTIVE COMPARATOR

Participants in this group receive only their usual treatments

Drug: Routine treatment

Interventions

Vitamin D3 DRUG

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.

Patients with vitamin D deficiency

Routine treatment DRUG

In this group, patients receive their usual medications and treatments

Patients without vitamin D deficiency

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes
• Having conscious satisfaction

You may not qualify if:

• 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

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 10, 2018
• Primary Completion: November 10, 2019
• Study Completion: February 10, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

IR (1)