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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585051
• Other study ID #: x335/08
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2012
• Last updated: April 24, 2012
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of medicine, Kantonsspital Bruderholz	Bruderholz/Basel	Basel-Landschaft

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baselland Bruderholz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBA1-c levels		3 and 6 months	No
Primary	24 hour mean blood pressure		3 and 6 months	No
Secondary	plasma glucose		3 and 6 months	No
Secondary	HOMA		6 months	No