The Effect of Vitamin D Supplementation on Arterial Stiffness in Diabetic Patients
1 other identifier
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Aug 2010
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedDecember 26, 2011
December 1, 2011
5 months
December 15, 2010
December 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
arterial stiffness
3 months
Secondary Outcomes (1)
blood pressure holter
3 months
Study Arms (1)
vitamin D
EXPERIMENTALBaby D3 drops
Interventions
Eligibility Criteria
You may qualify if:
- Diabetic patients
- Aged 18 years or older
- VITAMIN d deficiency
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel
Ẕerifin, Zerifin, 70300, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical center
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 26, 2011
Study Start
August 1, 2010
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
December 26, 2011
Record last verified: 2011-12