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

January 31, 2021 updated by: Leonor Cuadra Llopart

A Prospective Randomized Trial Comparing the Effects of 2 Vitamin D Supplementation Regimens in Elderly People After Hip Fracture Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip fractures and related disabilities are important public health issues for elderly people around the world. Attending the progressive aging of the population, an increase in the number of hip fractures is expected. In fact, some studies estimate that, globally, the incidence will exceed 6 million in 2050. In Spain, approximately 33,000 hip fracture occur annually, with an overall incidence of 517 cases per 100,000 elderly people. 90% occur in people over 64 years of age and the incidence increases exponentially beyond 80 years (> 64: 97/100000 inhabitants-year;> 85: 1898/100000 inhabitants-year).

Regarding the functional prognosis, those patients who survive the episode of the fracture often suffer a functional impairment. Outcomes for people who survive hip fracture are of concern, with more than one-quarter dying within a two-year period, and most of them not recovering their previous functional level. More than 10 % of survivors will be unable to return to their previous residence.

Vitamin D deficiency (serum 25 hydroxyvitamin D, 25OHD, level < 30 ng/mL) is commonly associated with hip fracture in elderly people. Without preventive treatment, however, vitamin D deficiency following hip fracture may result in proximal muscle weakness, pain, reduced dynamic balance and performance speed.

It is not clear how much Vitamin D must be taken in order to reach the optimal level. Although the benefits of supplementing patients with at least 800 to 1000 units (U)/day Vitamin D3 may be recognized, there is little information available to guide physicians regarding the appropriate management of hip fracture patients who may be severely Vitamin D deficient, specially in acute hip fracture patients.

A randomized controlled trial, including 50 older adults (aged 75 or over) who having suffered a hip fracture and with vitamin D deficiency, will be carried out. 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 Calcifediol oral daily along 5 days. For the control group will receive 16.000 U Calcifediol oral weekly along 5 weeks.

Functional status will be evaluated using Barthel Index, as well the proportion of patients reaching an optimal level of 25OHD (> 30 ng/mL) will be determined at discharge from hospital (1 month approximately), 3, 6 and 12 months of follow up.

Secondary measures include the Timed Up and Go test, gait speed test, Short Physical Performance Battery to compare the effect of the Vitamin D supplementation strategies on functional and muscle strength scales. In addition, to measure the strength and muscle mass will be used handheld dynamometer and bioimpedance analysis respectively

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcifediol (Vitamin D) loading-dose
Participants in the intervention group will receive calcifediol16.000 units (U) /day for five days
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)
Active Comparator: Calcifediol (Vitamin D) at clinical practice dose
Participants in the control group will receive 16.000 U / week for five weeks
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional gain
Time Frame: at 6 months of follow up
Defined as a 15-point improvement in the Barthel Index
at 6 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement serum Vitamin D (25OHD) levels
Time Frame: at baseline, 1, 3, 6 and 12 months of follow-up.
Defined as a vitamin D levels > 30 ng/mL
at baseline, 1, 3, 6 and 12 months of follow-up.
Improvement of muscle strength
Time Frame: at 3, 6 and 12 months of follow up.
Using handheld dynamometer to measure (kg)
at 3, 6 and 12 months of follow up.
Improvement of muscle mass
Time Frame: at 3, 6 and 12 months of follow up.
Using bioimpedance analysis to measure (kg)
at 3, 6 and 12 months of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonor Cuadra Llopart

Collaborators

Fundacio Salut i Envelliment UAB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

April 20, 2019

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITAMINA_D
  • 2017-001778-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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