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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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hemoDIALysis Patients

Intervention / Treatment
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* Drug: Cholecalciferol 100.000 UI administration
* Other: No vitamin D administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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25 OH-VITAmin D supplementation, muscle strength