Breast CancerPhase 2VITALNCT00867217
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
A Phase 2 study testing High Dose Vitamin D, Standard Dose Vitamin D3 and Letrozole 2.5mg in people with Breast Cancer, run by Qamar Khan at 2 sites in United States.
Trial summary
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- High Dose Vitamin D, Standard Dose Vitamin D3 and Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
- Serum 25OHD levels < 40 ng/ml
Who cannot join
- Severe or debilitating musculoskeletal pain
- Known metastatic disease
- History of renal stones
- History of hypercalcemia or hyperthyroidism
- Currently receiving adjuvant or neoadjuvant chemotherapy
- Currently receiving other investigational agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Westwood, Kansas, 66205
Cancer Centers of Kansas, P.A.
Wichita, Kansas, 67214
About this study
Official title: A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.
Read the detailed description
The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,
- Conditions
- Breast Cancer
- Being tested
- High Dose Vitamin D, Placebo, Standard Dose Vitamin D3, Letrozole 2.5mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Vitamin DDietary supplement
High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.
PlaceboDietary supplement
Placebo comparator
Standard Dose Vitamin D3Dietary supplement
Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)
Letrozole 2.5mgDrug
All subjects received letrozole as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Vitamin D | Experimental | High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). Receives: Dietary Supplement: High Dose Vitamin D; Dietary Supplement: Standard Dose Vitamin D3; Drug: Letrozole 2.5mg |
| Placebo | Placebo comparator | Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). Receives: Dietary Supplement: Placebo; Dietary Supplement: Standard Dose Vitamin D3; Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.
Measured: Change from Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qamar Khan
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, BTR Group
- Responsible party
- Sponsor-investigator, Qamar Khan, University of Kansas Medical Center
- Investigators
- Qamar J Khan, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867217
- Sponsor's protocol ID
- 11548
- Acronym
- VITAL
- Status last verified
- Jan 2018
- First submitted
- 20 Mar 2009
- Last updated
- 9 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
- ClinicalTrials.gov ID
- NCT00867217
- Acronym / sponsor ID
- VITAL / 11548
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Qamar KhanUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, BTR Group
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 9 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.
Detailed description
The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Vitamin D | Experimental | Dietary Supplement: High Dose Vitamin D, Dietary Supplement: Standard Dose Vitamin D3, Drug: Letrozole 2.5mgHigh Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: Standard Dose Vitamin D3, Drug: Letrozole 2.5mgPlacebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
- Serum 25OHD levels < 40 ng/ml
Key exclusion criteria (6 listed)
- Severe or debilitating musculoskeletal pain
- Known metastatic disease
- History of renal stones
- History of hypercalcemia or hyperthyroidism
- Currently receiving adjuvant or neoadjuvant chemotherapy
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 |
|---|---|---|
| High Dose Vitamin DHigh Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks. | Dietary supplement | High Dose Vitamin D |
| PlaceboPlacebo comparator | Dietary supplement | Placebo |
| Standard Dose Vitamin D3Standard Dose Vitamin D3 (600 IU of vitamin D3 daily) | Dietary supplement | High Dose Vitamin D, Placebo |
| Letrozole 2.5mgAll subjects received letrozole as standard of care. | Drug | High Dose Vitamin D, Placebo |
Primary outcome
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
Time frame: Change from Baseline to 24 Weeks
Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Qamar J Khan, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Dose Vitamin D, Standard Dose Vitamin D3 and Letrozole 2.5mg in people with Breast Cancer, run by Qamar Khan at 2 sites 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 2 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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 9 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Worsening of Musculoskeletal Symptoms (MS) (time frame: Change from Baseline to 24 Weeks). 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 9 Feb 2018.