Hip FracturePhase 4VITAMINA_DNCT03213886
The Effect of Supplementation of Vitamin D Deficiency in Older People With Acute Hip Fracture:
A Phase 4 study testing Calcifediol (Vitamin D) in people with Hip Fracture and Vitamin D Deficiency, run by Leonor Cuadra Llopart at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fracture, Vitamin D Deficiency
- What is being tested?
- Calcifediol (Vitamin D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 30 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Hip Fracture, Vitamin D Deficiency
- Being tested
- Calcifediol (Vitamin D)
- Keywords
- hip fracture, elderly, vitamin D, rehabilitation
- Medical subject headings
- Hip Fractures, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcifediol (Vitamin D)Drug
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:
- Will follow the usual hip fracture rehabilitation pathway.
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Calcifediol (Vitamin D) loading-dose | Experimental | Participants in the intervention group will receive calcifediol16.000 units (U) /day for five days Receives: Drug: Calcifediol (Vitamin D) |
| Calcifediol (Vitamin D) at clinical practice dose | Active comparator | Participants in the control group will receive 16.000 U / week for five weeks Receives: Drug: Calcifediol (Vitamin D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional gain
Defined as a 15-point improvement in the Barthel Index
Measured: at 6 months of follow up
Secondary outcomes (3)
Improvement serum Vitamin D (25OHD) levels
Defined as a vitamin D levels > 30 ng/mL
Measured: at baseline, 1, 3, 6 and 12 months of follow-up.
Improvement of muscle strength
Using handheld dynamometer to measure (kg)
Measured: at 3, 6 and 12 months of follow up.
Improvement of muscle mass
Using bioimpedance analysis to measure (kg)
Measured: at 3, 6 and 12 months of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jan 2018
- Primary completion20 Apr 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonor Cuadra Llopart
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Salut i Envelliment UAB
- Responsible party
- Sponsor-investigator, Leonor Cuadra Llopart, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213886
- Sponsor's protocol ID
- VITAMINA_D
- Other IDs
- 2017-001778-40, 2017
- Acronym
- VITAMINA_D
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duque G, Daly RM, Sanders K, Kiel DP. Vitamin D, bones and muscle: myth versus reality. Australas J Ageing. 2017 Mar;36 Suppl 1:8-13. doi: 10.1111/ajag.12408.
PubMed 28297132Hill TR, Aspray TJ. The role of vitamin D in maintaining bone health in older people. Ther Adv Musculoskelet Dis. 2017 Apr;9(4):89-95. doi: 10.1177/1759720X17692502. Epub 2017 Feb 14.
PubMed 28382112Dawson-Hughes B. Vitamin D and muscle function. J Steroid Biochem Mol Biol. 2017 Oct;173:313-316. doi: 10.1016/j.jsbmb.2017.03.018. Epub 2017 Mar 22.
PubMed 28341251Laiz A, Malouf J, Marin A, Longobardi V, de Caso J, Farrerons J, Casademont J. Impact of 3-Monthly Vitamin D Supplementation Plus Exercise on Survival after Surgery for Osteoporotic Hip Fracture in Adult Patients over 50 Years: A Pragmatic Randomized, Partially Blinded, Controlled Trial. J Nutr Health Aging. 2017;21(4):413-420. doi: 10.1007/s12603-016-0773-3.
PubMed 28346568Mak JC, Mason RS, Klein L, Cameron ID. An initial loading-dose vitamin D versus placebo after hip fracture surgery: randomized trial. BMC Musculoskelet Disord. 2016 Aug 11;17:336. doi: 10.1186/s12891-016-1174-9.
PubMed 27515154Sprague S, Petrisor B, Scott T, Devji T, Phillips M, Spurr H, Bhandari M, Slobogean GP. What Is the Role of Vitamin D Supplementation in Acute Fracture Patients? A Systematic Review and Meta-Analysis of the Prevalence of Hypovitaminosis D and Supplementation Efficacy. J Orthop Trauma. 2016 Feb;30(2):53-63. doi: 10.1097/BOT.0000000000000455.
PubMed 26429406Cuadra-Llopart L, Salva Casanovas A, Cerda Mas G, Jovell-Fernandez E. Efficacy of two calcifediol supplementation regimens in older adults post-hip fracture surgery. A clinical trial. Eur Geriatr Med. 2026 Feb;17(1):151-161. doi: 10.1007/s41999-025-01303-y. Epub 2025 Sep 15.
PubMed 40952661
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing the Effects of 2 Vitamin D Supplementation Regimens in Elderly People After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT03213886
- Acronym / sponsor ID
- VITAMINA_D / VITAMINA_D
- Conditions
- Hip Fracture, Vitamin D Deficiency
- Keywords
- hip fracture, elderly, vitamin D, rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Leonor Cuadra LlopartUniversity, hospital or other
- Collaborators
- Fundacio Salut i Envelliment UAB
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcifediol (Vitamin D) loading-dose | Experimental | Drug: Calcifediol (Vitamin D)Participants in the intervention group will receive calcifediol16.000 units (U) /day for five days |
| Calcifediol (Vitamin D) at clinical practice dose | Active comparator | Drug: Calcifediol (Vitamin D)Participants in the control group will receive 16.000 U / week for five weeks |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Calcifediol (Vitamin D) at clinical practice dose, Calcifediol (Vitamin D) loading-dose |
Primary outcome
Functional gain
Time frame: at 6 months of follow up
Defined as a 15-point improvement in the Barthel Index
3 secondary outcomes
Improvement serum Vitamin D (25OHD) levels
Time frame: 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.
Improvement of muscle mass
Time frame: at 3, 6 and 12 months of follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 28297132Duque G, Daly RM, Sanders K, Kiel DP. Vitamin D, bones and muscle: myth versus reality. Australas J Ageing. 2017 Mar;36 Suppl 1:8-13. doi: 10.1111/ajag.12408.
- Background: PubMed 28382112Hill TR, Aspray TJ. The role of vitamin D in maintaining bone health in older people. Ther Adv Musculoskelet Dis. 2017 Apr;9(4):89-95. doi: 10.1177/1759720X17692502. Epub 2017 Feb 14.
- Background: PubMed 28341251Dawson-Hughes B. Vitamin D and muscle function. J Steroid Biochem Mol Biol. 2017 Oct;173:313-316. doi: 10.1016/j.jsbmb.2017.03.018. Epub 2017 Mar 22.
- Background: PubMed 28346568Laiz A, Malouf J, Marin A, Longobardi V, de Caso J, Farrerons J, Casademont J. Impact of 3-Monthly Vitamin D Supplementation Plus Exercise on Survival after Surgery for Osteoporotic Hip Fracture in Adult Patients over 50 Years: A Pragmatic Randomized, Partially Blinded, Controlled Trial. J Nutr Health Aging. 2017;21(4):413-420. doi: 10.1007/s12603-016-0773-3.
- Background: PubMed 27515154Mak JC, Mason RS, Klein L, Cameron ID. An initial loading-dose vitamin D versus placebo after hip fracture surgery: randomized trial. BMC Musculoskelet Disord. 2016 Aug 11;17:336. doi: 10.1186/s12891-016-1174-9.
- Background: PubMed 26429406Sprague S, Petrisor B, Scott T, Devji T, Phillips M, Spurr H, Bhandari M, Slobogean GP. What Is the Role of Vitamin D Supplementation in Acute Fracture Patients? A Systematic Review and Meta-Analysis of the Prevalence of Hypovitaminosis D and Supplementation Efficacy. J Orthop Trauma. 2016 Feb;30(2):53-63. doi: 10.1097/BOT.0000000000000455.
- Derived from this study: PubMed 40952661Cuadra-Llopart L, Salva Casanovas A, Cerda Mas G, Jovell-Fernandez E. Efficacy of two calcifediol supplementation regimens in older adults post-hip fracture surgery. A clinical trial. Eur Geriatr Med. 2026 Feb;17(1):151-161. doi: 10.1007/s41999-025-01303-y. Epub 2025 Sep 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcifediol (Vitamin D) in people with Hip Fracture and Vitamin D Deficiency, run by Leonor Cuadra Llopart at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional gain (time frame: at 6 months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213886, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.