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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kantonsspital Baselland Bruderholz
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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)