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

Creighton University

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Dietary Supplement: placebo; Dietary Supplement: cholecalciferol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00511225

07-14571

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

47 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Will receive 10,000 IU of cholecalciferol weekly

Treatment:

Dietary Supplement: cholecalciferol

2

Placebo Comparator group

Description:

Will receive a identical appearing placebo weekly

Treatment:

Dietary Supplement: placebo