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Completed

NCT Number: NCT00511225

Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease

Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

About this study

The proposed study is be a randomized, double-blind, placebo-controlled trial of supplementation with oral vitamin D3.

Each subject will take a once-weekly capsule containing vitamin D3 or a an identical-appearing placebo for a treatment period of 15 weeks.

Subjects will be assessed for Bone pain and tenderness, Neuromuscular function, physical performance score, and Quality of life assessment.

A subset of subjects will have bone biopsies performed before and after intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • On dialysis
  • Likely to be able to complete the study
  • At least minimally ambulatory, with or without a walking aid (i.e., cane or walker)
  • Able to complete the various questionnaires interactively with the research nurse
  • Venous access that can be accomplished without unusual difficulty.

Treatment and study plan

Cholecalciferol

Dietary Supplement

10,000 IU weekly

Other names: Maximum D3®,Pro-Pharma LLA, Kirksville, MO

Placebo

Dietary Supplement

placebo capsule

Primary outcomes

  1. change in physical performance score

    Time frame: 15 weeks

Secondary outcomes

  1. Bone pain and tenderness

    Time frame: 15 weeks

  2. Neuromuscular function tests

    Time frame: 15 weeks

  3. Quality of life assessment

    Time frame: 15 weeks

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • Dialysis Clinic, Inc.

Registry information

Acronym: Neph

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Aug 3, 2007
Registry last updated
Jul 3, 2012

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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