Vitamin D Supplementation in Kidney Disease

NCT01229878 | Completed Results

• 1 other identifier: F7539-P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind placebo controlled pilot study to determine if vitamin D supplementation in hemodialysis (HD) patients will improve physical function and cognition. HD patients have a high prevalence of vitamin D deficiency, cognitive impairment, and physical impairment. Despite standard clinical care with active IV vitamin D during dialysis, HD patients still have markedly low levels of nutritional or dietary vitamin D. IV treatment with vitamin D during dialysis is aimed at treating HD related bone disease. Recent literature shows that oral or nutritional vitamin D has multiple extra-skeletal effects including improvement in cognition and physical function. In this study, the investigators plan to administer oral vitamin D to vitamin D deficient HD patients already receiving standard care with IV vitamin D therapy. Patients will be randomized to receive either placebo or 50,000 IU of vitamin D (cholecalciferol) weekly for 6 months. The investigators' specific aims are to 1) Assess the benefits of correcting nutritional vitamin D deficiency on cognitive and physical function in HD patients receiving routine standard of care, 2) Assess the feasibility of recruiting HD patients for this study, and 3) Evaluate the proposed regimen for safely and effectively increasing nutritional vitamin D levels with oral supplementation. The investigators anticipate that correction of nutritional vitamin D deficiency to optimal levels will improve the high prevalence of cognitive impairment and physical impairment in this population. These results will be used as evidence to support a larger study aimed at treating nutritional vitamin D deficiency in all patients receiving HD. These results may also contribute to a change in current guidelines which place little emphasis on the monitoring and treatment of nutritional vitamin D levels in HD patients. These results are important for the Veteran dialysis population since many of them are required to perform high-level cognitive tasks such as management of complex medical regimens and physical tasks such as orchestrating independent transportation to and from HD sessions and multiple physician appointments.

Conditions

Renal Dialysis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Hip Flexor Strength

  Neuromuscular Function - strength testing of hip flexors. Hip flexor strength measured using a push-pull muscle strength dynamometer. Participants performed a hip flexor exercise 3 times at each visit. The final result at each time point was an average of the 3 tries. Outcome measure is change between baseline and 6 months.

  6 months

Secondary Outcomes (3)

• Quality-of-Life Self Assessment

  6 months

• Neuropsychological Assessments

  6 months

• Immune Function Assessments

  6 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Hemodialysis Patients randomized to take Vitamin D supplements

Dietary Supplement: Cholecalciferol (Vitamin D)

Placebo

PLACEBO COMPARATOR

Hemodialysis Patients randomized to take placebo pills

Dietary Supplement: Cholecalciferol (Vitamin D)

Interventions

Cholecalciferol (Vitamin D) DIETARY_SUPPLEMENT

50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months

Placebo; Vitamin D

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving HD for at least two weeks
• Receiving IV vitamin D supplementation according to National Kidney Foundation guidelines.
• Male or female with an between the ages of 45-89 years
• Veteran outpatient or stable community living center patient
• Able to ambulate independently or with an assistive device for at least 20 feet

You may not qualify if:

• OH vitamin D level \< 25 ng/ml
• Hypercalcemia
• Active malignancy within 6 months
• Receiving intravenous antibiotics for infection
• History of Dementia
• Hemoglobin \< 8.5g
• History of conditions that interfere with postural instability (e.g. cerebellar disease, vestibular disease or any others that may present)
• Poor compliance with dialysis treatments (history of skipping 2 treatments per month for \> 2 months)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Kel Morin
• Organization: VA Providence Healthcare System

kel.morin@va.gov

347-346-0380

Study Officials

• James B Post, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: December 1, 2011
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)