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Does Correction of 25 OH-VITAmin D With Cholecalciferol Supplementation Increase Muscle Strength in hemoDIALysis Patients?

NCT04262934 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-08-11

No results posted yet for this study

Summary

Muscle strength decreases as renal failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous studies have linked low 25OH-vitamin D (25OHD) concentrations to the loss of the muscle strength and low physical performances. Data on native vitamin D and muscle function are scarce in the chronic renal failure (CKD) population, but low 25OHD levels have been associated with poor muscle strength. In this protocol of an ongoing study named VITADIAL testing if cholecalciferol supplementation in hemodialysis patients with low 25OHD improve their muscle strength.

Conditions

  • hemoDIALysis Patients

Interventions

DRUG

Cholecalciferol 100.000 UI administration

One oral Administration - Every month

OTHER

No vitamin D administration

No vitamin D administration

Sponsors & Collaborators

  • Institut Phoceen de Nephrologie

    lead OTHER

Principal Investigators

  • Stanislas BATAILLE, MD · Institut Phoceen de Nephrologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2024-06-08
Completion
2024-06-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262934 on ClinicalTrials.gov