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

End Stage Renal Disease Clinical Trial

— Neph  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511225
• Other study ID #: 07-14571
• Status: Completed
• Phase: N/A
• First received: August 1, 2007
• Last updated: June 29, 2012
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• cholecalciferol
10,000 IU weekly
• placebo
placebo capsule

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in physical performance score		15 weeks	No
Secondary	Bone pain and tenderness		15 weeks	No
Secondary	Neuromuscular function tests		15 weeks	No
Secondary	Quality of life assessment		15 weeks	No