Hypovitaminosis DNCT01858051
Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients
A study testing Cholecalciferol in people with Hypovitaminosis D, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2017
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age ≥18 years
- English or Spanish speaking
- Scheduled for preoperative clinic assessment
- Scheduled to have elective hip or knee joint replacement surgery
- Not taking more than 1000 IU of either cholecalciferol or ergocalciferol daily
Who cannot join
- Unable to provide consent
- Inability to comply with study protocol
- History of anemia (hematocrit <25%)
- History of renal stones or hypercalcemia
- Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma)
- Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication)
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery
In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as an independent risk factor for infections of implanted hardware.
In general, the majority of PJIs become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. Hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements.
Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To date, perioperative vitamin D optimization strategies have not been reported. Therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery.
- Conditions
- Hypovitaminosis D
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Vitamin D, Perioperative immune regulation, LL-37, Hospital-acquired infection, Surgical site infections
- Medical subject headings
- Vitamin D Deficiency, Cross Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol Bolus Dose | Active comparator | 70 patients will receive a bolus pre-operative oral dose of 150,000 IU cholecalciferol 3-7 days before surgery Receives: Dietary Supplement: Cholecalciferol |
| Cholecalciferol Divided Dose | Active comparator | 70 patients will receive an oral 100,000 IU cholecalciferol dose 3-7 days before surgery and an additional oral 50,000 IU cholecalciferol dose on post-operative day 1 Receives: Dietary Supplement: Cholecalciferol |
| Sugar Pill | Placebo comparator | 35 patients will receive a placebo pill orally 3-7 days before surgery Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D status 5 days following supplementation with cholecalciferol
Subjects will receive 150,000 IU or 100,000 IU cholecalciferol (vs. placebo) 3-7 days before surgery during their pre-operative assessment. Vitamin D status on the day of pre-operative assessment will be compared to vitamin D status on the day of surgery. To assess vitamin D status, we will measure serum: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL-37; 5) Albumin; and 6) Calcium levels.
Measured: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
Secondary outcomes (3)
Change in pre-surgical vitamin D status 1 day after surgery
Subjects will receive either pre-operative supplementation with 150,000 IU or pre-operative supplementation with 100,000 IU cholecalciferol plus 50,000 IU cholecalciferol on post-operative day 1 (vs. placebo). Vitamin D status will be compared between the day of surgery and post-operative day 1. To assess vitamin D status, we will measure: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL37; 5) Albumin; and 6) Calcium levels.
Measured: Patients will be followed between the day of surgery and an average duration of 1 day after surgery
Change in pre-surgical vitamin D status 2 weeks after surgery
Subjects will receive either pre-operative supplementation with 150,000 IU or pre-operative supplementation with 100,000 IU cholecalciferol plus 50,000 IU cholecalciferol on post-operative day 1 (vs. placebo). Vitamin D status will be compared between the day of surgery and post-operative day 10-18. To assess vitamin D status, we will measure: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL37; 5) Albumin; and 6) Calcium levels.
Measured: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
Change in pre-surgical vitamin D status 3 months after surgery
Subjects will receive either pre-operative supplementation with 150,000 IU or pre-operative supplementation with 100,000 IU cholecalciferol plus 50,000 IU cholecalciferol on post-operative day 1 (vs. placebo). Vitamin D status will be compared between the day of surgery and post-operative day 80-100. To assess vitamin D status, we will measure: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL37; 5) Albumin; and 6) Calcium levels.
Measured: Patients will be followed between the day of surgery and an average of 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bio-Tech Pharmacal, Inc.
- Responsible party
- Principal investigator, Sadeq A. Quraishi, Massachusetts General Hospital
- Investigators
- Sadeq A Quraishi, MD, MMSc, Principal investigator, Harvard Medical School, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858051
- Sponsor's protocol ID
- 2013P001071
- Status last verified
- Mar 2017
- First submitted
- 16 May 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery
- ClinicalTrials.gov ID
- NCT01858051
- Acronym / sponsor ID
- 2013P001071
- Conditions
- Hypovitaminosis D
- Keywords
- Vitamin D, Perioperative immune regulation, LL-37, Hospital-acquired infection, Surgical site infections
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bio-Tech Pharmacal, Inc.
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 May 2013 (estimated)
- 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.
In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as an independent risk factor for infections of implanted hardware.
In general, the majority of PJIs become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. Hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements.
Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To date, perioperative vitamin D optimization strategies have not been reported. Therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol Bolus Dose | Active comparator | Dietary Supplement: Cholecalciferol70 patients will receive a bolus pre-operative oral dose of 150,000 IU cholecalciferol 3-7 days before surgery |
| Cholecalciferol Divided Dose | Active comparator | Dietary Supplement: Cholecalciferol70 patients will receive an oral 100,000 IU cholecalciferol dose 3-7 days before surgery and an additional oral 50,000 IU cholecalciferol dose on post-operative day 1 |
| Sugar Pill | Placebo comparator | Dietary Supplement: Placebo35 patients will receive a placebo pill orally 3-7 days before surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Age ≥18 years
- English or Spanish speaking
- Scheduled for preoperative clinic assessment
- Scheduled to have elective hip or knee joint replacement surgery
Key exclusion criteria (7 listed)
- Unable to provide consent
- Inability to comply with study protocol
- History of anemia (hematocrit <25%)
- History of renal stones or hypercalcemia
- Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma)
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 |
|---|---|---|
| Cholecalciferol | Dietary supplement | Cholecalciferol Bolus Dose, Cholecalciferol Divided Dose |
| Placebo | Dietary supplement | Sugar Pill |
Primary outcome
Change in vitamin D status 5 days following supplementation with cholecalciferol
Time frame: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
Subjects will receive 150,000 IU or 100,000 IU cholecalciferol (vs. placebo) 3-7 days before surgery during their pre-operative assessment. Vitamin D status on the day of pre-operative assessment will be compared to vitamin D status on the day of surgery. To assess vitamin D status, we will measure serum: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL-37; 5) Albumin; and 6) Calcium levels.
3 secondary outcomes
Change in pre-surgical vitamin D status 1 day after surgery
Time frame: Patients will be followed between the day of surgery and an average duration of 1 day after surgery
Change in pre-surgical vitamin D status 2 weeks after surgery
Time frame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
Change in pre-surgical vitamin D status 3 months after surgery
Time frame: Patients will be followed between the day of surgery and an average of 90 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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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.
Sadeq A Quraishi, MD, MMSc principal investigator
Harvard Medical School, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Hypovitaminosis D, run by Massachusetts General Hospital 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Mar 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in vitamin D status 5 days following supplementation with cholecalciferol (time frame: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days). 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 30 Mar 2017.