Effect of Vitamin D Supplementation on Balance in CKD

NCT ID: NCT03710161

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2020-03-13

Brief Summary

Patients with end-stage renal disease on dialysis (ESRD5D) are 4-5x more likely to suffer from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further, 70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become routine care for many in this patient population, but evidence is lacking to support this practice. The proposed projects objective is to gather needed preliminary data regarding the effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D.

Detailed Description

In 2009, ~6% of the annual Medicare budget was spent to treat people with end-stage renal disease on dialysis (ESRD5D), making chronic kidney disease (CKD) an important and costly health problem affecting the United States. These patients are 4-5x more likely to suffer from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further, 70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become routine care for many in this patient population; without evidence to support this practice. While studies on the elderly document the effect of vitamin D in decreasing fall risk, findings are inconclusive for those elderly individuals with ESRD5D. The proposed projects objective is to gather needed preliminary data regarding the effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D. Thirty patients with ESRD5D will be recruited and randomized into two groups: 1) 4000 or 2) 800 IU oral, vitamin D taken daily. Men and women (ages 21-70 years) will be recruited from among patients receiving hemodialysis at a UNMC-directed dialysis facility. Other inclusion criteria include 1) likely to be able to complete the study; 2) ambulatory, without a walking aid; 3) able to complete questionnaires interactively with a research nurse; and 4) greater than 3 months on hemodialysis. Exclusion criteria include patients on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that would interfere with vitamin D absorption; vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, drug therapies for osteoporosis. All patients will be receiving standard of care per their nephrologist. Functional data will be collected at baseline, three, and six months. Data collected will include balance, muscle strength, and falls. Data to monitor vitamin D levels and calcium will be pulled from their medical record. There is no follow up after the six month long study.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Keywords

dialysis; end stage renal disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

4000 IU Vitamin D

4000 IU Vitamin D taken daily for six months

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Vitamin D taken in two different dosages daily for six months.

800 IU Vitamin D

800 IU Vitamin D taken daily for six months

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

Vitamin D taken in two different dosages daily for six months.

Interventions

Vitamin D

Vitamin D taken in two different dosages daily for six months.

Intervention Type: DRUG

Other Intervention Names

25(OH)D

Eligibility Criteria

Inclusion Criteria

• must be likely to be able to complete the study
• must be able to walk without a walking aid
• must be able to complete questionnaires interactively research staff
• must have been on dialysis for greater than 3 months
• all patients must be receiving standard of care per their nephrologist

Exclusion Criteria

• peritoneal dialysis
• an allergy to vitamin D
• liver disease
• intestinal disorders that would interfere with vitamin D absorption
• taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or other drug therapies for osteoporosis
• are pregnant

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenna Yentes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska at Omaha

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0608-18-FB

Identifier Type: -

Identifier Source: org_study_id