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

Creighton University47 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

End Stage Renal Disease

Interventions

cholecalciferolDIETARY_SUPPLEMENT

10,000 IU weekly

placeboDIETARY_SUPPLEMENT

placebo capsule

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Creighton University

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

change in physical performance score

Time frame: 15 weeks

Secondary Outcomes

Bone pain and tenderness

Time frame: 15 weeks

Neuromuscular function tests

Time frame: 15 weeks

Quality of life assessment

Time frame: 15 weeks

Data from ClinicalTrials.gov

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