Clinical trial NCT01585051: Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Keywords: vitamin D
blood pressure
typ 2 diabetes mellitus
blood glucose
HbA1c
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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)

Primary outcomes:
measure: Change in HBA1-c levels
timeFrame: 3 and 6 months
measure: 24 hour mean blood pressure
timeFrame: 3 and 6 months
Secondary outcomes:
measure: plasma glucose
timeFrame: 3 and 6 months
measure: HOMA
timeFrame: 6 months
Other outcomes:
Locations:
city: Bruderholz/Basel
country: Switzerland
facility: Department of medicine, Kantonsspital Bruderholz
state: Basel-Landschaft
Study officials:
affiliation: Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland
name: Reto Krapf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jehle S, Lardi A, Felix B, Hulter HN, Stettler C, Krapf R. Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study. Swiss Med Wkly. 2014 Mar 20;144:w13942. doi: 10.4414/smw.2014.13942.