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

hemoDIALysis Patients Clinical Trial

— VITADIAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262934
• Other study ID #: VITADIAL
• Status: Recruiting
• Phase: Phase 3
• Start date: January 8, 2018
• Est. completion date: June 8, 2024

Study information

• Verified date: March 2022
• Source: Institut Phoceen de Nephrologie
• Contact: Nathalie PEDINIELLI
• Phone: +33 (0)4 91 15 94 10
• Email: recherche.clinique.ipn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 8, 2024
• Est. primary completion date: June 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• hemoDIALysis Patients

Intervention

Drug:
• Cholecalciferol 100.000 UI administration
One oral Administration - Every month

Other:
• No vitamin D administration
No vitamin D administration

Locations

Country	Name	City	State
France	Pedinielli	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Phoceen de Nephrologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

•   Institut Phocéen de Néphrologie