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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
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus Type 2
 Drug: 25(OH) vitamin D
Drug: 0.9 % NaCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Kantonsspital Baselland Bruderholz:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • plasma glucose [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • HOMA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D
Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D
 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.
Placebo Comparator: placebo
administration of 0.9 % NaCl as a placebo
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585051

Locations
Switzerland
Department of medicine, Kantonsspital Bruderholz
Bruderholz/Basel, Basel-Landschaft, Switzerland, CH-4101
Sponsors and Collaborators
Kantonsspital Baselland Bruderholz
Investigators
Principal Investigator: Reto Krapf, MD Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
  More Information

No publications provided

Responsible Party: Reto Krapf, Professor of Medicine, Kantonsspital Bruderholz
ClinicalTrials.gov Identifier: NCT01585051     History of Changes
Other Study ID Numbers: x335/08
Study First Received: April 23, 2012
Last Updated: April 24, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Baselland Bruderholz:
vitamin D
blood pressure
typ 2 diabetes mellitus
blood glucose
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013