- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585051
Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D
April 24, 2012 updated by: Reto Krapf, Kantonsspital Baselland Bruderholz
Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus
The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Landschaft
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Bruderholz/Basel, Basel-Landschaft, Switzerland, CH-4101
- Department of medicine, Kantonsspital Bruderholz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Men and women, ages ≥18 years
- Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment
- Independent living at home
- On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study
- Stable glucose control for 2 months by any approved method including insulin
Exclusion criteria
- Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type)
- Patients on hemodialysis, with hyperparathyroidism or active cancer disease
- Patients with known metabolic bone disease
- Laboratory evidence of kidney (eGFR < 60 ml/min) or liver disease
- Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history)
- 25(OH) vitamin D levels at baseline > 70 nmol/L
- Calciuria (> 8 mmol/24 hours as measured by 24 hour urine collections)
- Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause
- Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study)
- Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above
- History of binge eating or wt gain or loss exceeding 6 kg in past 18 months
- Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: vitamin D
Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D
|
300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.
|
Placebo Comparator: placebo
administration of 0.9 % NaCl as a placebo
|
1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HBA1-c levels
Time Frame: 3 and 6 months
|
3 and 6 months
|
24 hour mean blood pressure
Time Frame: 3 and 6 months
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma glucose
Time Frame: 3 and 6 months
|
3 and 6 months
|
HOMA
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Reto Krapf, MD, Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
April 23, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 25, 2012
Study Record Updates
Last Update Posted (Estimate)
April 25, 2012
Last Update Submitted That Met QC Criteria
April 24, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- x335/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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