The Effect of Vitamin D Supplementation on Arterial Stiffness in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fany Tusia, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01500005
First received: December 15, 2010
Last updated: December 23, 2011
Last verified: December 2011
  Purpose

The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide.

Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.

Recently, increasing amount of evidence suggests that vitamin D may influence various nonskeletal medical conditions, including cardiovascular disease, hypertension, diabetes, cancer, autoimmune disorders and more. The purpose of this trial is to investigate the effect of vitamin D supplementation on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and inflammation in vitamin D deficient diabetic patients.


Condition Intervention
Diabetes
Drug: Baby D3 drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on Arterial Stiffness, Blood Pressure, Oxidative Stress and Inflammation in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • arterial stiffness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure holter [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D
Baby D3 drops
Drug: Baby D3 drops
2000-4000 iu per day
Other Name: vitamin D

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic patients
  • Aged 18 years or older
  • VITAMIN d deficiency

Exclusion Criteria:

  • CCT<30
  • A history of treatment with vitamin D supplementation in the last 3 months
  • Treatment with nitrates
  • Uncontrolled heart failure
  • Uncontrolled hypertension and/or any change in the hypertensive medications during the last 1 month.
  • Any malignancy with life expectancy of less then 1 year
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500005

Locations
Israel
Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Shlomit koren, MD Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: Fany Tusia, medical center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01500005     History of Changes
Other Study ID Numbers: shlomit10
Study First Received: December 15, 2010
Last Updated: December 23, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014