Vitamin D Supplementation in Chronic Stable Heart Failure

NCT01292720 | Completed Phase 3

• 1 other identifier: VITD-HI
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

In cross-sectional and prospective cohort studies, vitamin D deficiency is associated with increased mortality, cardiovascular events including sudden cardiac death and stroke, diabetes, hypertension and impaired function of the immune and musculoskeletal system. The action of vitamin D on the cardiovascular system regulates cardiac function, endothelial and vascular smooth muscle, and, the renin-angiotensin system. Treatment with sufficiently high doses of vitamin D may represent a promising and inexpensive intervention option. To date, there are few data on the effect of cholecalciferol treatment in patients with chronic heart failure. The primary objective of this study is to investigate whether oral vitamin D supplementation improves chronic heart failure (measured with the surrogate parameter of NT-proBNP levels at month 0 and 6).

Conditions

Heart Failure; Vitamin D Deficiency

Keywords

vitamin D deficiency, vitamin D insufficiency, heart failure

Outcome Measures

Primary Outcomes (1)

• NT-pro BNP

  Change from Baseline in NT-pro BNP serum level at 6 months

  month 0, 6

Secondary Outcomes (4)

• Percentage of patients with 25(OH)D ≥ 30 ng/ml at month 6

  6 months

• Serum calcium

  month 0, 6

• DXA

  month 0,12

• Urinary calcium

  month 0,6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (herbal oil)

Drug: Placebo

Vitamin D

EXPERIMENTAL

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

Cholecalciferol 90,000 IU followed by weekly 24,000 IU for 24 weeks of vitamin D3 (total dose: 666,000 IU)

Also known as: Vitamin D

Vitamin D

Placebo DRUG

Placebo in matching volumes

Also known as: Herbal Oil

Placebo

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stable heart failure (NYHA II-IV, ejection fraction ≤ 40%)
• ≥ 45 years
• (OH) Vitamin D ≤ 30ng/ml

You may not qualify if:

• hypercalcemia (total serum calcium \> 2.65 mmol/l OR ionized calcium \> 1.35 mmol/l)
• nephro-/urolithiasis (≤1 year)
• known granulomatous diseases (active tuberculosis, sarcoidosis)
• pregnancy

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Heart Failure; Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Karin Amrein, MD

  Medical University of Graz

  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: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 9, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

AU (1)