Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001778-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundacio Salut i Envelliment UAB | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcifediol (Vitamin D) loading-dose | Experimental | Participants in the intervention group will receive calcifediol16.000 units (U) /day for five days |
|
| Calcifediol (Vitamin D) at clinical practice dose | Active Comparator | Participants in the control group will receive 16.000 U / week for five weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional gain | Defined as a 15-point improvement in the Barthel Index | at 6 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement serum Vitamin D (25OHD) levels | Defined as a vitamin D levels > 30 ng/mL | at baseline, 1, 3, 6 and 12 months of follow-up. |
| Improvement of muscle strength | Using handheld dynamometer to measure (kg) |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28297132 | Background | 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. | |
| 28382112 | Background | Hill 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D002112 | Calcifediol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| at 3, 6 and 12 months of follow up. |
| Improvement of muscle mass | Using bioimpedance analysis to measure (kg) | at 3, 6 and 12 months of follow up. |
| 28341251 | Background | Dawson-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. |
| 28346568 | Background | Laiz 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. |
| 27515154 | Background | Mak 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. |
| 26429406 | Background | Sprague 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. |
| 40952661 | Derived | Cuadra-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. |
| D007869 |
| Leg Injuries |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |