Vitamin D DeficiencyPhase 1/2NCT03066817
Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
A Phase 1/2 study testing Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL] and Propylene Glycol in people with Vitamin D Deficiency and Polytrauma, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
Although vitamin D is known to play a major role in multiple organ functions in healthy adults, including bone homeostasis, its role in the unique population of orthopaedic polytrauma patients has not been well described. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitamin D Deficiency, Polytrauma, Orthopedic Disorder
- What is being tested?
- Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL] and Propylene Glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to Mar 2020
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age 18-65 years
- One or more orthopaedic injuries on admission
- Admission injury severity score (ISS)≥16
- Anticipated stay in hospital of more than 7 days
Who cannot join
- Pregnancy (if patient becomes pregnant during the study, she will be removed from the study)
- End stage kidney disease
- Patients on furosemide, thiazide, or corticosteroid therapy
- Patients with chronic liver disease
- Patients with recent history of vitamin D supplementation more than 5000 IU/day
- Patients actively undergoing chemo- or immunotherapy
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- Patients with hematologic and solid malignancies
- Patients receiving treatment for osteoporosis
- Patients with "nothing per mouth" status secondary to any preceding procedures involving their GI system (e.g. patients with colectomy performed on this admission secondary to gunshot wound to abdomen)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Role of Vitamin D in Regulation of Bone Homeostasis in Orthopaedic Polytrauma Patients
Although vitamin D is known to play a major role in multiple organ functions in healthy adults, including bone homeostasis, its role in the unique population of orthopaedic polytrauma patients has not been well described. The aim of this therapeutic randomized placebo-controlled feasibility study is to determine the effect of vitamin D supplementation initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for all the patients on admission, and the intervention arm will receive a one-time dose of ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7 days after the initial draw or at discharge, whichever occurs first. Patients' daily immobilization status, baseline characteristics and clinical outcomes will be recorded. Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone turnover markers levels associated with the intervention.
Read the detailed description
Sixty polytrauma patients presenting to Jacobi Medical Center will be screened for eligibility according to strict inclusion and exclusion criteria by study personnel on admission. Medical history, physical examination, and laboratory findings will be collected and assessed to ensure that patients meet the inclusion and exclusion criteria. Eligible subjects will be enrolled after obtaining informed consent from either the subject or health care proxy if the subject is not able to participate in the decision-making process secondary to his injuries or mental status. As this dose of vitamin D has not been previously studied in pregnant subjects, female subjects will be counseled on potential pregnancy risks and will undergo urine pregnancy testing prior to administration of the investigational agent/placebo. Female patients testing positive for pregnancy will be removed from the study. Upon enrollment, study personnel will assign subjects a study ID and record this information in a password-protected data collection document.
All enrolled subjects will have blood draws by phlebotomy or nursing staff for the above-mentioned bone turnover markers once consent is obtained. This will include specimen collection and processing for the following serum levels in both study arms: 25(OH)-D, PTH, collagen type I C-telopeptide, calcium, phosphorus, osteocalcin, and alkaline phosphatase. This initial specimen collection will occur in the interval between 0 and 72 hours of hospital admission.
Collected specimen will be assigned unique identifiers corresponding to patients' study IDs and delivered to core labs at Jacobi Medical Center. From there, the specimen will be sent to an outside testing facility (Northwell Laboratories, Lake Success, NY), where specimen processing will occur. Normal laboratory values will be established by the outside testing facility according to CLIA standards.
The study personnel will liaise with the JMC Main or Satellite Pharmacy to alert them regarding newly enrolled study subjects. The pharmacist will then assign patients according to randomization algorithm in a 1:1 ratio to intervention and control arms, with 30 patients in each group by the end of the study accrual. The pharmacist will then prepare and transport the investigational agent or placebo to the subject's location for administration by nursing staff.
The intervention cohort will receive 400,000IU liquid ergocalciferol (50cc of 8000IU/cc Calcidol solution) via oral, NG tube, or gastrostomy route.
The control cohort will receive 50cc of propylene glycol as placebo via oral, NG tube, or gastrostomy route.
A repeat specimen collection of above-mentioned bone turnover markers will commence either at 7 days if patient is still inpatient, or at discharge, whichever occurs first. The specimens obtained at that time will be treated in the same manner as the initial specimens.
For each enrolled subject, the investigators will collect data from hospital presentation to discharge on standard demographics, routine laboratory results, clinical and injury characteristics and hospital course data (length of stay, in-hospital mortality, mobilization status, associated inpatient procedures and complications).
- Conditions
- Vitamin D Deficiency, Polytrauma, Orthopedic Disorder
- Being tested
- Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL], Propylene Glycol
- Keywords
- Vitamin D, Deficiency, Insufficiency, Bone turnover, Bone healing, Polytrauma
- Medical subject headings
- Vitamin D Deficiency, Multiple Trauma, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]Drug
Also called Calcidol
50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose.
Propylene GlycolDrug
50cc of propylene glycole will be given to participants as one-time dose, used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D control | Placebo comparator | The control cohort will receive 50cc of propylene glycol as placebo via oral, nasogastric tube, or gastrostomy route on hospital admission. Receives: Drug: Propylene Glycol |
| Vitamin D intervention cohort | Experimental | The intervention cohort will receive a one-time 400,000 IU liquid ergocalciferol (50cc of Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]) via oral, nasogastric tube, or gastrostomy route on hospital admission. Receives: Drug: Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL] |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)-D serum level in relation to other serum markers of bone turnover
Serum Vitamin D Level, Serum Parathyroid Hormone Level, Serum C-terminal Telopeptide Level, Serum Osteocalcin Level
Measured: 1 week
Secondary outcomes (2)
Hospital length of stay
Patient hospital length of stay if patient leaves before hospital day 7
Measured: 1 week
In-hospital morbidity and mortality
Statistics regarding in-hospital morbidity and mortality
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jul 2017
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Waiting for annual IRB progress report to be reviewed and approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Orthopedic Trauma, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Milan Sen, MD, Principal investigator, Montefiore Medical Center / Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066817
- Sponsor's protocol ID
- MSMB01
- Status last verified
- Apr 2019
- First submitted
- 23 Feb 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Role of Vitamin D in Regulation of Bone Homeostasis in Orthopaedic Polytrauma Patients
- ClinicalTrials.gov ID
- NCT03066817
- Acronym / sponsor ID
- MSMB01
- Conditions
- Vitamin D Deficiency, Polytrauma, Orthopedic Disorder
- Keywords
- Vitamin D, Deficiency, Insufficiency, Bone turnover, Bone healing, Polytrauma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Waiting for annual IRB progress report to be reviewed and approved
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Collaborators
- Foundation of Orthopedic Trauma, Montefiore Medical Center
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Feb 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.
Although vitamin D is known to play a major role in multiple organ functions in healthy adults, including bone homeostasis, its role in the unique population of orthopaedic polytrauma patients has not been well described. The aim of this therapeutic randomized placebo-controlled feasibility study is to determine the effect of vitamin D supplementation initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for all the patients on admission, and the intervention arm will receive a one-time dose of ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7 days after the initial draw or at discharge, whichever occurs first. Patients' daily immobilization status, baseline characteristics and clinical outcomes will be recorded. Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone turnover markers levels associated with the intervention.
Detailed description
Sixty polytrauma patients presenting to Jacobi Medical Center will be screened for eligibility according to strict inclusion and exclusion criteria by study personnel on admission. Medical history, physical examination, and laboratory findings will be collected and assessed to ensure that patients meet the inclusion and exclusion criteria. Eligible subjects will be enrolled after obtaining informed consent from either the subject or health care proxy if the subject is not able to participate in the decision-making process secondary to his injuries or mental status. As this dose of vitamin D has not been previously studied in pregnant subjects, female subjects will be counseled on potential pregnancy risks and will undergo urine pregnancy testing prior to administration of the investigational agent/placebo. Female patients testing positive for pregnancy will be removed from the study. Upon enrollment, study personnel will assign subjects a study ID and record this information in a password-protected data collection document.
All enrolled subjects will have blood draws by phlebotomy or nursing staff for the above-mentioned bone turnover markers once consent is obtained. This will include specimen collection and processing for the following serum levels in both study arms: 25(OH)-D, PTH, collagen type I C-telopeptide, calcium, phosphorus, osteocalcin, and alkaline phosphatase. This initial specimen collection will occur in the interval between 0 and 72 hours of hospital admission.
Collected specimen will be assigned unique identifiers corresponding to patients' study IDs and delivered to core labs at Jacobi Medical Center. From there, the specimen will be sent to an outside testing facility (Northwell Laboratories, Lake Success, NY), where specimen processing will occur. Normal laboratory values will be established by the outside testing facility according to CLIA standards.
The study personnel will liaise with the JMC Main or Satellite Pharmacy to alert them regarding newly enrolled study subjects. The pharmacist will then assign patients according to randomization algorithm in a 1:1 ratio to intervention and control arms, with 30 patients in each group by the end of the study accrual. The pharmacist will then prepare and transport the investigational agent or placebo to the subject's location for administration by nursing staff.
The intervention cohort will receive 400,000IU liquid ergocalciferol (50cc of 8000IU/cc Calcidol solution) via oral, NG tube, or gastrostomy route.
The control cohort will receive 50cc of propylene glycol as placebo via oral, NG tube, or gastrostomy route.
A repeat specimen collection of above-mentioned bone turnover markers will commence either at 7 days if patient is still inpatient, or at discharge, whichever occurs first. The specimens obtained at that time will be treated in the same manner as the initial specimens.
For each enrolled subject, the investigators will collect data from hospital presentation to discharge on standard demographics, routine laboratory results, clinical and injury characteristics and hospital course data (length of stay, in-hospital mortality, mobilization status, associated inpatient procedures and complications).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D control | Placebo comparator | Drug: Propylene GlycolThe control cohort will receive 50cc of propylene glycol as placebo via oral, nasogastric tube, or gastrostomy route on hospital admission. |
| Vitamin D intervention cohort | Experimental | Drug: Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]The intervention cohort will receive a one-time 400,000 IU liquid ergocalciferol (50cc of Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]) via oral, nasogastric tube, or gastrostomy route on hospital admission. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females age 18-65 years
- One or more orthopaedic injuries on admission
- Admission injury severity score (ISS)≥16
- Anticipated stay in hospital of more than 7 days
Key exclusion criteria (9 listed)
- Pregnancy (if patient becomes pregnant during the study, she will be removed from the study)
- End stage kidney disease
- Patients on furosemide, thiazide, or corticosteroid therapy
- Patients with chronic liver disease
- Patients with recent history of vitamin D supplementation more than 5000 IU/day
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 |
|---|---|---|
| Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]Also: Calcidol50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose. | Drug | Vitamin D intervention cohort |
| Propylene Glycol50cc of propylene glycole will be given to participants as one-time dose, used as placebo | Drug | Vitamin D control |
Primary outcome
25(OH)-D serum level in relation to other serum markers of bone turnover
Time frame: 1 week
Serum Vitamin D Level, Serum Parathyroid Hormone Level, Serum C-terminal Telopeptide Level, Serum Osteocalcin Level
2 secondary outcomes
Hospital length of stay
Time frame: 1 week
In-hospital morbidity and mortality
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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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.
Milan Sen, MD principal investigator
Montefiore Medical Center / Jacobi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL] and Propylene Glycol in people with Vitamin D Deficiency and Polytrauma, run by New York City Health and Hospitals Corporation at 1 site in United States.
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 4 inclusion and 9 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: paused, as of the sponsor's last update on 4 Apr 2019. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
25(OH)-D serum level in relation to other serum markers of bone turnover (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.