NCT03213886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

June 27, 2017

Last Update Submit

January 31, 2021

Conditions

Hip FractureVitamin D Deficiency

Keywords

hip fractureelderlyvitamin Drehabilitation

Outcome Measures

Primary Outcomes (1)

  • Functional gain

    Defined as a 15-point improvement in the Barthel Index

    at 6 months of follow up

Secondary Outcomes (3)

  • Improvement serum Vitamin D (25OHD) levels

    at baseline, 1, 3, 6 and 12 months of follow-up.

  • Improvement of muscle strength

    at 3, 6 and 12 months of follow up.

  • Improvement of muscle mass

    at 3, 6 and 12 months of follow up.

Study Arms (2)

Calcifediol (Vitamin D) loading-dose

EXPERIMENTAL

Participants in the intervention group will receive calcifediol16.000 units (U) /day for five days

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

Drug: Calcifediol (Vitamin D)

Interventions

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: 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)

Calcifediol (Vitamin D) at clinical practice doseCalcifediol (Vitamin D) loading-dose

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (7)

  • 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.

    PMID: 28297132BACKGROUND

  • 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.

    PMID: 28382112BACKGROUND

  • 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.

    PMID: 28341251BACKGROUND

  • 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.

    PMID: 28346568BACKGROUND

  • 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.

    PMID: 27515154BACKGROUND

  • 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.

    PMID: 26429406BACKGROUND

  • 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. 2025 Sep 15. doi: 10.1007/s41999-025-01303-y. Online ahead of print.

    PMID: 40952661DERIVED

MeSH Terms

Conditions

Hip FracturesVitamin D Deficiency

Interventions

CalcifediolVitamin D

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 11, 2017

Study Start

January 1, 2018

Primary Completion

April 20, 2019

Study Completion

July 30, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)