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Effect of vitamin D supplementation and resistance training on muscle, bone, and inflammatory parameters in maintenance hemodialysis patients

Effect of vitamin D supplementation and resistance training on body composition, physical capacity, inflammatory parameters and bone mineral metabolism in maintenance hemodialysis patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3j787t
Enrollment
Unknown
Registered
2018-08-07
Start date
2018-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal dialysis

Interventions

Group 1: 7 patients on maintenance hemodialysis will receive Cholecalciferol (vitamin D) suplementation, capsule orally, dose of 50000 IU, once a week for 16 weeks, and resistance exercise training (
Group 2: 7 patients on maintenance hemodialysis will orally receive a capsule of placebo once a week for 16 weeks, and resistance exercise training (3 times a week for 16 weeks)
Group 3: 7 patients on maintenance hemodialysis that will receive Cholecalciferol (vitamin D) suplementation, dose of 50000 IU, once a week for 16 weeks, capsule orally,and will not perform resistance
Group 4: 7 patients on maintenance hemodialysis will receive orally a capsule of placebo once a week for 16 weeks and will not perform resistance exercise training.
Other
E02.760.169.063.500.387.875

Sponsors

Associação Prudentina de Educação e Cultura APEC
Lead Sponsor
Faculdade de Ciências e Tecnologia UNESP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals older than 18 years; with chronic kidney disease on hemodialysis for a period greater than or equal to three months in the Hospital of Presidente Prudente “Doutor Domingos Leonardo Cerávolo”, Presidente Prudente, São Paulo, Brazil; do not have contraindications to physical activity; and accept and sign the Informed Consent.

Exclusion criteria

Exclusion criteria: Individuals unable to understand the procedures performed; prior diagnosis of coronary artery disease; positive exercise test for cardiac ischemia; Patients who have suffered stroke; patients with cancer, liver failure, chronic infection or acute in activity; uncontrolled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic); with amputated limbs; those that received cholecalciferol supplementation in the last 6 months; use of medications that affect body composition, such as corticosteroids and antiretroviral therapy.

Design outcomes

Primary

MeasureTime frame
Significant increase in muscle strength and functional capacity in the assessments before and after intervention period assessed by dynamometry and functional capacity tests, respectively. (There is no referential percentage, only the statistically significant increase is the expected outcome);Significant improve in inflammatory parameters (cytokines assessed by ELISA and immune system cells labeling by flow cytometry). (There is no referential percentage, only the statistically significant increase is the expected outcome).

Secondary

MeasureTime frame
Significant increase in soluble Klotho serum concentration assessed by ELISA. (There is no referential percentage, only the statistically significant increase is the expected outcome).

Countries

Brazil

Contacts

Public ContactBarbara;Fábio Vogt;Lira

Associação Prudentina de Educação e Cultura APEC ;Faculdade de Ciências e Tecnologia UNESP

barbara_pv@yahoo.com.br;fabio.lira@unesp.br+55-18-32291052;+55-18-32295388

Outcome results

None listed

Source: REBEC (via WHO ICTRP)