Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reto Krapf, Kantonsspital Bruderholz
ClinicalTrials.gov Identifier:
NCT01585051
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012

April 23, 2012
April 24, 2012
January 2009
June 2010   (final data collection date for primary outcome measure)
  • Change in HBA1-c levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 24 hour mean blood pressure [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01585051 on ClinicalTrials.gov Archive Site
  • plasma glucose [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • HOMA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: 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.
  • Drug: 0.9 % NaCl
    1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months
  • Active Comparator: vitamin D
    Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D
    Intervention: Drug: 25(OH) vitamin D
  • Placebo Comparator: placebo
    administration of 0.9 % NaCl as a placebo
    Intervention: Drug: 0.9 % NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2010
June 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01585051
x335/08
No
Reto Krapf, Kantonsspital Bruderholz
Kantonsspital Baselland Bruderholz
Not Provided
Principal Investigator: Reto Krapf, MD Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
Kantonsspital Baselland Bruderholz
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP