Overview

The Effect of Supplementation of Vitamin D Deficiency in Older People With Acute Hip Fracture:

Status:
Completed
Trial end date:
2020-07-30
Target enrollment:
0
Participant gender:
All
Summary
This study will be done to evaluate the effect of load dose of vitamin D compared to the dose of usual clinical practice, in improving mobility and reducing disability in older people following a hip fracture.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Leonor Cuadra Llopart
Collaborator:
Fundacio Salut i Envelliment UAB
Treatments:
Calcifediol
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria: Patients aged 75 years or over with fragility hip fracture (requiring
surgical treatment) and vitamin D deficiency; able to provide informed consent, either
directly or via the person responsible.

Definitions:

- Fragility hip fracture: 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: 25OHD serum levels < 30 ng / mL

Exclusion Criteria:

- Presence of severe functional dependence prior to fracture of the femur (Barthel Index
< 35 points)

- Diagnosis of dementia to a moderate degree (defined on "Global Deterioration Scale"
(GDS) and "Functional Assessment Staging" (FAST), GDS-FAST > 5).

- Medical conditions that contraindicate receiving vitamin D supplementation:
hypercalcemia (calcemia> 10.5 mg / dL), hyperparathyroidism; chronic renal failure
with glomerular filtration rate (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).

- Reduced life expectancy (<12 months) due to the presence of advanced concomitant or
end-of-life conditions.