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CHolecalciferol vs calcifediol effect on mineral bone metabolism of hemodialysis patients.

An unicentric, open, randomized and crossover clinical trial to evaluate vitamin D supplementation effect of colecalciferol versus calcidiol in mineral metabolism in hemodialisis patients.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2019-003101-97-ES
Enrollment
20
Registered
2019-12-02
Start date
2020-02-18
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

VITAMIN D DEFICIENCY IN HEMODIALISIS PATIENTS

Interventions

Trade Name: HIDROFEROL Pharmaceutical Form: Oral solution INN or Proposed INN: CALCIFEDIOL CAS Number: 19356-17-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.

Sponsors

FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years old 2. Under treatment at Hemodialysis Unit in FJD. 3. Under treatment with vitamin D suplements 4. Willing to participate and signing ICF. . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Alergia o hipersensibilidad conocidas a calcidiol, colecalciferol, o a cualquiera de sus componentes 2. Hipercalcemia. 3. Insuficiencia Cardíaca severa (clase funcional NYHA IV) 4. Mujeres potencialmente fértiles que no estén dispuestas a utilizar un método anticonceptivo que se considere efectivo 5. Embarazo o lactancia 6. Participantes en otro ensayo clínico con medicamento en los 28 días previos al inicio del reclutamiento. 7. Negativa a participar 8. A criterio del investigador, incapacidad del paciente para comprender o cumplir los procedimientos del estudio 9. Tratamiento actual con fármacos que puedan interferir en los fenómenos de absorción, distribución, metabolismo o excreción de la vitamina D: 10. Antiepilépticos como Fenitoína, Fenobarbital o Primidona, así como otros inductores enzimáticos 11. Colestiramina, colestipol u orlistat 12. Laxantes tipo Parafina (emuliquen®, hodernal®, ordelax®), y aceite mineral (glicerol en solución rectal o supositorios de glicerina): El resto de laxantes sí está permitido (estimulantes tipo Bisacodilo, incrementadores del bolo tipo Plantago Ovata, osmóticos, lactulosa) 13. Digitálicos 14. Sales de Magnesio 15. Verapamilo 16. Corticosteroides 17. Patologías que puedan interferir en la farmacocinética o en la farmacodinámicade la vitamina D: 18. Enfermedad hepática descompensada 19. Enfermedad Inflamatoria Intestinal 20. Sarcoidosis, Tuberculosis u otras enfermedades granulomatosas 21. Calcemia > 10,5 mg/dl, antecedentes de hipercalciuriao litiasis cálcica

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effect of vitamin D suplementation with Cholecalciferol vs calcifediol in plasma levels of calcium, phosphorum and FGF23.;Secondary Objective: To compare the effect of vitamin D suplementation with Cholecalciferol vs calcifediol in plasma levels of PTH and 25-OH-VD.;Primary end point(s): The primary analysis of the study will be the difference in calcium, phosphorus, 25OH vitamina D, PTH and FGF-23 levels between groups;Timepoint(s) of evaluation of this end point: 8 weeks—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: NA—

Countries

Spain

Contacts

Public ContactUNIDAD DE INVESTIGACION CLINICA

FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE

mireia.arcas@fjd.es+349155048003214

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026