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

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

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.

Study Overview

• Status: Recruiting
• Conditions: hemoDIALysis Patients
• Intervention / Treatment: Drug: Cholecalciferol 100.000 UI administration; Other: No vitamin D administration

Detailed Description

Prospective open randomized French multicenter study. All patients will have 25OHD levels ≤50nmol/L at randomization. One group will receive 100 000 UI cholecalciferol once a month during 6 months, the other group will receive no treatment during 6 months.

In order to randomize patients with 25OHD ≤50nmol/L, supplemented patients will undergo a 3 months wash-out period renewable 3 times (maximum of 12 months wash-out) until 25OHD reaches a level≤50nmol/L.

The main objective of this study is to analyze if a 6 months period of oral cholecalciferol (i.e. native vitamin D) supplementation improves muscle strength of hemodialysis patients with low 25OHD vitamin D levels. Muscle strength will be assessed at 0, 3 and 6 months, by handgrip strength measured with a quantitative dynamometer.

Secondary objectives are 1) to analyze 25OHD plasma levels after vitamin D wash-out and/or supplementation, as well as factors associated with 25OHD lowering speed during wash-out and 2) to analyze if this supplementation improves patient's autonomy, reduces frailty risk and improves quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nathalie PEDINIELLI; Phone Number: +33 (0)4 91 15 94 10; Email: recherche.clinique.ipn@gmail.com

Study Locations

• France
  • Marseille, France, 13006
    • Recruiting
    • Pedinielli
    • Principal Investigator: Stanislas BATAILLE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion Criteria:

  • under hemodialysis for more than 3 months
  • aged over 18 years-old
  • gave their consent

• Non-inclusion criteria :

  • 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
  • 25OHD>50nmol/L without vitamin D treatment
  • cholecalciferol intolerance or allergy

• Exclusion Criteria:

  • 25OHD>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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cholecalciferol treatment; Arm A : Cholecalciferol 100.000 UI - oral - every month	Drug: Cholecalciferol 100.000 UI administration; One oral Administration - Every month
Active Comparator: No treatment; Arm B : No vitamin D administration	Other: No vitamin D administration; No vitamin D administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's autonomy after 6 months period of oral cholecalciferol	Katz Index of Independence in Activities of Daily Living (ADL)	At 6 months post randomization (for patients treated)
Patient's frailty risk after 6 months period of oral cholecalciferol	The Frail Non-Disabled (FiND) Questionnaire	At 6 months post randomization (for patients treated)
Patient's quality of life after 6 months period of oral cholecalciferol	Kidney Disease Quality of Life (KDQOL-SFtm) Questionnaire	At 6 months post randomization (for patients treated)

Collaborators and Investigators

• Sponsor: Institut Phoceen de Nephrologie
• Investigators: Principal Investigator: Stanislas BATAILLE, MD, Institut Phoceen de Nephrologie

Publications and helpful links

General Publications

• 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.

Helpful Links

• Institut Phocéen de Néphrologie

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): June 8, 2024
• Study Completion (Anticipated): June 8, 2024

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: muscle strength; 25 OH-VITAmin D supplementation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: VITADIAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No