EUCTR2017-001778-40-ES
Active, not recruiting
Phase 1
A Prospective Randomized Trial Comparing the Effect of 2 vitamin D supplementation regimens in elderly people after hip fracture surgery
eonor Cuadra Llopart0 sitesOctober 2, 2017
ConditionsHip fracture and vitamin D deficiencyTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsHIDROFEROL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hip fracture and vitamin D deficiency
- Sponsor
- eonor Cuadra Llopart
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged \> or \=75 years with hip fracture by fragility and vitamin D deficiency.
- •Definitions:
- •\* Fracture by fragility: understood as such those that are produced by trauma of low intensity (for example, falls from the own height in standing or smaller)
- •\* Vitamin D deficiency: 25\-OH\-D3 serum levels \<30 ng / mL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •\* Presence of severe functional dependence prior to fracture of the femur (I. Barthel \<35 points)
- •\* Diagnosis of dementia to a moderate degree (defined on the Reisberg scale as GDS\-FAST\> 5\).
- •\* Medical conditions that contraindicate receiving vitamin D supplementation
- •\- hypercalcemia (calcemia\> 10\.5 mg / dL),
- •\- hyperparathyroidism
- •\- chronic renal failure with GFR \<30 mL / min,
- •\- calcium lithiasis
- •\- pathologies with risk of hypercalcemia (tuberculosis, sarcoidosis ...), as well as pathologies involving intestinal malabsorption.
- •\- Hypersensitivity to the active substance or to any of the excipients.
- •\* Use of drugs that interact with the use of vitamin D and with the risk of causing hypercalcemia (phenytoin, phenobarbital, primidone, digoxin).
Outcomes
Primary Outcomes
Not specified
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