A Trial of Vitamin D Therapy in Patients With Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by University Hospitals Cleveland Medical Center.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT01125436

First received: May 17, 2010

Last updated: July 1, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 17, 2010

Last Updated Date

July 1, 2011

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak VO2 [ Time Frame: baseline ]
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
Peak VO2 [ Time Frame: 6 months ]
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01125436 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

muscle strength [ Time Frame: baseline ]
strength of the proximal lower extremity muscles
muscle strength [ Time Frame: 6 months ]
strength of the proximal lower extremity muscles

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Trial of Vitamin D Therapy in Patients With Heart Failure

Official Title ^ICMJE

A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure

Brief Summary

The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure
Aerobic Capacity
Strength

Intervention ^ICMJE

Dietary Supplement: Cholecalciferol
50,000 IU weekly for 6 months

Other Name: Vitamin D
Dietary Supplement: Cholecalciferol
Placebo weekly for 6 months

Study Arms

Experimental: Cholecalciferol
Nutritional supplement

Intervention: Dietary Supplement: Cholecalciferol
Placebo Comparator: placebo
Intervention: Dietary Supplement: Cholecalciferol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

NYHA class II-IV
Able to walk
Serum 25OHD level 37.5 ng/ml or less
Fully titrated on heart failure medications

Exclusion Criteria:

Osteoporosis
Primary hyperparathyroidism or hypercalcemia.
Nephrolithiasis
Hemo or peritoneal dialysis and/or creatinine of > 2.5
Current use of daily vitamin D greater than 400 IU, corticosteroids,PTH, androgen or estrogen
Current illicit drug user or > 3 alcoholic drinks a day
Metastatic or advanced cancer
Myocardial infarction in the preceding 6 months
Medications which can lower vitamin D levels or bioavailability

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01125436

Other Study ID Numbers ^ICMJE

1KL2RR024990( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Rebecca S. Boxer, MD, Case Western Reserve University

Study Sponsor ^ICMJE

University Hospitals Cleveland Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

University Hospitals Cleveland Medical Center

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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