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NCT01229878 · ClinicalTrials.gov registry record · NA

Vitamin D Supplementation in Kidney Disease

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT01229878: Completed NA study, sponsored by VA Office of Research and Development.

NCT01229878 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01229878, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • DIETARY_SUPPLEMENT Cholecalciferol (Vitamin D)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-12-01
Est. Completion 2022-12-30
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT01229878 record still lists

NCT01229878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol (Vitamin D) is the first listed.

NCT01229878 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01229878 about?

NCT01229878 is a clinical study titled "Vitamin D Supplementation in Kidney Disease". 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 clin...

What is the current status of trial NCT01229878?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2011-12-01. Estimated completion is 2022-12-30.

What interventions are being tested in trial NCT01229878?

The interventions under investigation include: Cholecalciferol (Vitamin D) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01229878?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01229878's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01229878, the US trial registry maintained by the National Library of Medicine. NCT01229878 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.