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Completed

NCT Number: NCT01125436

A 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals/Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily

Other names: Vitamin D

Primary outcomes

  1. Peak VO2

    Time frame: change from baseline to 6 months

    Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Secondary outcomes

  1. Leg Proximal Muscle Strength

    Time frame: change from baseline to 6 months

    Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension

  2. 6 Minute Walk Distance

    Time frame: Change from baseline to 6 months

    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).

  3. Timed Get Up and Go

    Time frame: Change from baseline to 6 months

    stand from chair walk 3 meters, return to chair and sit

Other outcomes

  1. Serum Aldosterone

    Time frame: change from baseline to 6 months

    Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.

  2. Plasma Renin Activity

    Time frame: change in renin from baseline to 6 months

    Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 18, 2010
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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