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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03213886
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Fundacio Salut i Envelliment UAB
Information provided by (Responsible Party):
Leonor Cuadra Llopart, Consorci Sanitari de Terrassa

Brief 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.

Condition or disease Intervention/treatment Phase
Hip Fracture Vitamin D Deficiency Drug: Calcifediol (Vitamin D) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing the Effects of 2 Vitamin D Supplementation Regimens in Elderly People After Hip Fracture Surgery
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 20, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Functional gain [ Time Frame: at 6 months of follow up ]
    Defined as a 15-point improvement in the Barthel Index


Secondary Outcome Measures :
  1. 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

  2. Improvement of muscle strength [ Time Frame: at 3, 6 and 12 months of follow up. ]
    Using handheld dynamometer to measure (kg)

  3. Improvement of muscle mass [ Time Frame: at 3, 6 and 12 months of follow up. ]
    Using bioimpedance analysis to measure (kg)



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213886


Contacts
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Contact: Leonor Cuadra, MD 0034 937310007 ext 2898 lcuadra@cst.cat
Contact: Esther Jovell, PhD 0034 937003657 ejovell@cst.cat

Locations
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Spain
Consorci Sanitari de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08227
Contact: Leonor Cuadra, MD    0034 937310007 ext 2898    lcuadra@cst.cat   
Contact: Esther Jovell, PhD         
Sponsors and Collaborators
Leonor Cuadra Llopart
Fundacio Salut i Envelliment UAB
Publications:
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Responsible Party: Leonor Cuadra Llopart, Medical Doctor, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT03213886    
Other Study ID Numbers: VITAMINA_D
2017-001778-40 ( EudraCT Number )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leonor Cuadra Llopart, Consorci Sanitari de Terrassa:
hip fracture
elderly
vitamin D
rehabilitation
Additional relevant MeSH terms:
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Vitamin D Deficiency
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents