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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: cholecalciferol; Dietary Supplement: placebo

• Registration Number: NCT00511225
• Lead Sponsor: Creighton University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-03
• Study Start: 2007-09
• Primary Completion: 2010-06
• Study Completion: 2011-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cholecalciferol	Will receive 10,000 IU of cholecalciferol weekly
2	placebo	Will receive a identical appearing placebo weekly

Primary Outcome Measures

Name	Time	Method
change in physical performance score	15 weeks

Secondary Outcome Measures

Name	Time	Method
Bone pain and tenderness	15 weeks
Neuromuscular function tests	15 weeks
Quality of life assessment	15 weeks

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States