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

NCT01585051 | Completed Phase 3

• 1 other identifier: x335/08
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus Type 2

Keywords

vitamin D; blood pressure; typ 2 diabetes mellitus; blood glucose; HbA1c

Outcome Measures

Primary Outcomes (2)

• Change in HBA1-c levels

  3 and 6 months

• 24 hour mean blood pressure

  3 and 6 months

Secondary Outcomes (2)

• plasma glucose

  3 and 6 months

• HOMA

  6 months

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D

Drug: 25(OH) vitamin D

placebo

PLACEBO COMPARATOR

administration of 0.9 % NaCl as a placebo

Drug: 0.9 % NaCl

Interventions

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.

vitamin D

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• (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)

Sponsors & Collaborators

• Kantonsspital Baselland Bruderholz: lead

Study Sites (1)

Department of medicine, Kantonsspital Bruderholz

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

Location

Related Publications (1)

• 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.

  PMID: 24652692 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vitamin D; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Reto Krapf, MD

  Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

CH (1)