Effect of Vitamin D Supplementation on Balance in CKD

NCT03710161 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 0608-18-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Keywords

dialysis; end stage renal disease

Outcome Measures

Primary Outcomes (3)

• Timed up and go

  This measures fall risk. The measure is a length of time it takes to complete a walking test. A longer score indicates a longer amount of time to complete the test. A shorter amount of time is considered better.

  Baseline

• Fullerton Advanced Balance Scale

  This 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.

  Baseline

• Gait Speed Over 20 Meters

  Walking speed is measured over distance of 20 meters. Walking speed is measured in meters per second. A faster walking speed is considered better. Time in seconds needed to cover 20 meters while walking is reported.

  Baseline

Secondary Outcomes (1)

• Strength of the Quadriceps (Right Leg)

  Baseline

Study Arms (2)

4000 IU Vitamin D

EXPERIMENTAL

4000 IU Vitamin D taken daily for six months

Drug: Vitamin D

800 IU Vitamin D

ACTIVE COMPARATOR

800 IU Vitamin D taken daily for six months

Drug: Vitamin D

Interventions

Vitamin D DRUG

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

Also known as: 25(OH)D

4000 IU Vitamin D; 800 IU Vitamin D

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Laura Graeff-Armas
• Organization: University of Nebraska Medical Center

laura.armas@unmc.edu

402-559-6310

Study Officials

• Jenna Yentes, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: July 8, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: December 1, 2023
• Results First Posted: June 14, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)