A Trial of Vitamin D Therapy in Patients With Heart Failure

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: Cholecalciferol; Dietary supplement: Cholecalciferol

Detailed Description

The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.

A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients > 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals/Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• New York Heart Association (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, parathyroid hormone (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cholecalciferol; Nutritional supplement	Dietary supplement: Cholecalciferol; 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily; Other Names: Vitamin D; Dietary supplement: Cholecalciferol; Weekly placebo plus 800 calcium alone
Placebo Comparator: placebo; Weekly placebo plus 800 calcium daily	Dietary supplement: Cholecalciferol; 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily; Other Names: Vitamin D; Dietary supplement: Cholecalciferol; Weekly placebo plus 800 calcium alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2	Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity	change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Proximal Muscle Strength	Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension	change from baseline to 6 months
6 Minute Walk Distance	The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL).	Change from baseline to 6 months
Timed Get Up and Go	stand from chair walk 3 meters, return to chair and sit	Change from baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Aldosterone	Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.	change from baseline to 6 months
Plasma Renin Activity	Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.	change in renin from baseline to 6 months

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Rebecca Boxer, MD, Case Western Reserve Univerity

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Strength; Aerobic Capacity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 1KL2RR024990 (U.S. NIH Grant/Contract)