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A Trial of Vitamin D Therapy in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Cholecalciferol
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Aerobic Capacity, Strength

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals/Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecalciferol

placebo

Arm Description

Nutritional supplement

Weekly placebo plus 800 calcium daily

Outcomes

Primary Outcome Measures

Peak VO2
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Secondary Outcome Measures

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
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).
Timed Get Up and Go
stand from chair walk 3 meters, return to chair and sit

Full Information

First Posted
May 17, 2010
Last Updated
July 18, 2022
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT01125436
Brief Title
A Trial of Vitamin D Therapy in Patients With Heart Failure
Official Title
A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Western Reserve University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Aerobic Capacity, Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
Nutritional supplement
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Weekly placebo plus 800 calcium daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
Weekly placebo plus 800 calcium alone
Primary Outcome Measure Information:
Title
Peak VO2
Description
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Leg Proximal Muscle Strength
Description
Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension
Time Frame
change from baseline to 6 months
Title
6 Minute Walk Distance
Description
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).
Time Frame
Change from baseline to 6 months
Title
Timed Get Up and Go
Description
stand from chair walk 3 meters, return to chair and sit
Time Frame
Change from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Serum Aldosterone
Description
Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.
Time Frame
change from baseline to 6 months
Title
Plasma Renin Activity
Description
Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.
Time Frame
change in renin from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Boxer, MD
Organizational Affiliation
Case Western Reserve Univerity
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals/Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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A Trial of Vitamin D Therapy in Patients With Heart Failure

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