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
  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:


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
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: 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 by Kantonsspital Baselland Bruderholz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 15, 2014