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

NCT04262934 | Unknown Phase 3

• 1 other identifier: VITADIAL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

25 OH-VITAmin D supplementation; muscle strength

Outcome Measures

Primary Outcomes (1)

• Muscle strength evaluation after 6 months period after cholecalciferol or no vitamin D treatment

  Muscle strength will be assessed by handgrip strength measured with a quantitative dynamometer

  At 6 months after randomization

Secondary Outcomes (3)

• Patient's autonomy after 6 months period of oral cholecalciferol

  At 6 months post randomization (for patients treated)

• Patient's frailty risk after 6 months period of oral cholecalciferol

  At 6 months post randomization (for patients treated)

• Patient's quality of life after 6 months period of oral cholecalciferol

  At 6 months post randomization (for patients treated)

Study Arms (2)

Cholecalciferol treatment

EXPERIMENTAL

Arm A : Cholecalciferol 100.000 UI - oral - every month

Drug: Cholecalciferol 100.000 UI administration

No treatment

ACTIVE COMPARATOR

Arm B : No vitamin D administration

Other: No vitamin D administration

Interventions

Cholecalciferol 100.000 UI administration DRUG

One oral Administration - Every month

Cholecalciferol treatment

No vitamin D administration OTHER

No vitamin D administration

No treatment

Eligibility Criteria

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

You may qualify if:

• under hemodialysis for more than 3 months
• aged over 18 years-old
• gave their consent
• non fluent French speaker
• incapacity to provide consent or to answer questionnaires
• pregnancy or breast feeding
• cognitive impairment
• bedridden or life expectancy \<1 year
• active cancer
• uncontrolled hyperparathyroidism as defined by the K-DIGO (iPTH\>9x normal laboratory maximal value), cinacalcet treatment or hypocalcemia \<2.0 mmol/L or hypercalcemia \>2.7mmol/L
• past osteoporosis fracture
• treatment with active vitamin D
• unable to perform handgrip measurement
• OHD\>50nmol/L without vitamin D treatment
• cholecalciferol intolerance or allergy

You may not qualify if:

• OHD\>50nmol/L after 12 months wash-out
• hypercalcemia \>2.7mmol/L
• hyperparathyroidism (iPTH\>9x normal laboratory maximal value) during wash-out or after randomization if patient is in the no treatment group
• hypoparathyroidism (iPTH\<3x normal laboratory lower value) in a patient receiving cholecalciferol
• cholecalciferol intolerance or allergy
• death, renal transplantation
• pregnancy
• consent withdrawal
• renal recuperation allowing hemodialysis to stop
• unability to perform handgrip

Sponsors & Collaborators

• Institut Phoceen de Nephrologie: lead

Study Sites (1)

Pedinielli

Marseille, 13006, France

RECRUITING

Related Publications (1)

• Bataille S, Pedinielli N, Carreno E, Prezelin-Reydit M, Chauveau P, Jean G, Robert T, Bobot M, Seret G, Jouve E, Lavainne F, Serveaux M, Vrigneaud L, Gentile S. VITADIAL "Does correction of 25 OH-VITAmin D with cholecalciferol supplementation increase muscle strength in hemoDIALysis patients?": study protocol for a randomized controlled trial. Trials. 2021 May 25;22(1):364. doi: 10.1186/s13063-021-05302-9.

  PMID: 34034786 DERIVED

Related Links

• Institut Phocéen de Néphrologie

MeSH Terms

Interventions

Cholecalciferol; Organization and Administration

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Health Services Administration

Study Officials

• Stanislas BATAILLE, MD

  Institut Phoceen de Nephrologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie PEDINIELLI

CONTACT

+33 (0)4 91 15 94 10; recherche.clinique.ipn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 10, 2020
• Study Start: January 8, 2018
• Primary Completion: June 8, 2024
• Study Completion: June 8, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)