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

NCT03213886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-02

No results posted yet for this study

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.

Conditions

  • Hip Fracture
  • Vitamin D Deficiency

Interventions

DRUG

Calcifediol (Vitamin D)

After surgical treatment, participants with vitamin D deficiency (25OHD \< 30 ng/mL) will be randomly allocated to an intervention group or control group. For the intervention group, participants will receive 16. 000 U oral Calcifediol daily for 5 days. For the control group, participants will receive 16.000 U oral Calcifediol weekly for 5 weeks. Both groups: 1. Will follow the usual hip fracture rehabilitation pathway. 2. 25OHD serum levels will be measured after 4 weeks. Depending on the serum 25OHD level, the patients will receive different vitamin D strategies (according to the protocol) Patients will be monitored for up to 12 months after the discharge from the hospital, with 3 clinic visits at 3, 6 and 12 months (to determine serum vitamin D levels and to evaluate functional status)

Sponsors & Collaborators

  • Fundacio Salut i Envelliment UAB

    collaborator OTHER

  • Leonor Cuadra Llopart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-04-20
Completion
2020-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213886 on ClinicalTrials.gov