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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014