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OpenTrials
Completed

NCT Number: NCT01585051

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of medicine, Kantonsspital Bruderholz

Bruderholz/Basel, Basel-Landschaft, CH-4101, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

25(OH) vitamin D

Drug

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.

0.9 % NaCl

Drug

1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months

Primary outcomes

  1. Change in HBA1-c levels

    Time frame: 3 and 6 months

  2. 24 hour mean blood pressure

    Time frame: 3 and 6 months

Secondary outcomes

  1. plasma glucose

    Time frame: 3 and 6 months

  2. HOMA

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kantonsspital Baselland Bruderholz

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 25, 2012
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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