A Phase 2 interventional study of Vitamin D3 and Vitamin D3 in Muscle Pain and Joint Pain, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by HealthPartners Institute · Phase 2, Interventional, and Supportive care
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 116 is above the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Vitamin D3
Drug: Vitamin D3
Cholecalciferol capsule, 4000IU, daily for 6 months
cholecalciferol capsule, 600 IU, daily for 6 months
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
Time frame: baseline to 6 months
Change in Hand Grip Strength
Time frame: baseline to 6 months
Change in PROMIS Physical Functioning Questionnaire
PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).
Time frame: baseline to 6 months
Average Percent Adherence to Vitamin D Interventio
adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months
Time frame: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months
Serum Estradiol Concentrations
Time frame: baseline and 6 months
Change in Steady State Concentrations of Serum Anastrazole and Letrozole
Difference in steady state concentrations in plasma from baseline to 6 months
Time frame: baseline to 6 months
Whole Body Bone Mineral Density
GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use
Time frame: From Baseline and 6 months of D3 supplementation
Vitamin D Binding Protein Genotype
Time frame: Baseline
| Milestone | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Started | 57 | 59 |
| Completed | 57 | 56 |
| Not completed | 0 | 3 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Started an excluded medication | 0 | 1 |
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
| units on a scale | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale | -0.2 ± 0.7 | -0.5 ± 0.9 |
| pounds | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Change in Hand Grip Strength | 1.8 ± 10.6 | 1.0 ± 7.6 |
PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).
| units on a scale | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Change in PROMIS Physical Functioning Questionnaire | 0.6 ± 4.9 | 1.7 ± 6.9 |
adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months
| % of adherence for each treatment arm | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Average Percent Adherence to Vitamin D Interventio | 95 | 95 |
| pg/ml | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Baseline | 2.83 ± 0.1 | 2.77 ± 0.1 |
| 6 months | 2.94 ± 0.16 | 3.0 ± 0.12 |
Difference in steady state concentrations in plasma from baseline to 6 months
| mg/L | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| anastrozole | -1.31 ± 10.67 | 2.4 ± 5.36 |
| letrozole | 2.16 ± 9.69 | -0.83 ± 16.4 |
GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use
| gm/cm2 | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Whole Body Bone Mineral Density | 1.1 ± 0.12 | 1.12 ± 0.13 |
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D3 4000 IU | — | 0/57 (0%) | 35/57 (61.4%) |
| Vitamin D3 600 IU | — | 0/56 (0%) | 32/56 (57.1%) |
| Event | Vitamin D3 4000 IU | Vitamin D3 600 IU |
|---|---|---|
| Gastrointestinal complaintsGastrointestinal disorders | 12/57 | 7/56 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 10/57 | 10/56 |
| RespiratoryRespiratory, thoracic and mediastinal disorders | 9/57 | 3/56 |
| Nervous system disordersNervous system disorders | 7/57 | 3/56 |
| Skin problemsSkin and subcutaneous tissue disorders | 5/57 | 5/56 |
| Reproductive and breast issuesReproductive system and breast disorders | 2/57 | 5/56 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 5/57 | 3/56 |
| InjuriesInjury, poisoning and procedural complications | 3/57 | 4/56 |
| Surgical and medical proceduresSurgical and medical procedures | 4/57 | 1/56 |
| CardiacCardiac disorders | 2/57 | 3/56 |
| Age, Continuous(years) | Vitamin D3 4000 IU | Vitamin D3 600 IU | Total |
|---|---|---|---|
| Mean | 61.4 ± 8.4 | 60.3 ± 9.3 | 60.9 ± 8.8 |
| Sex: Female, Male(Participants) | Vitamin D3 4000 IU | Vitamin D3 600 IU | Total |
|---|---|---|---|
| Female | 57 | 56 | 113 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vitamin D3 4000 IU | Vitamin D3 600 IU | Total |
|---|---|---|---|
| United States | 57 | 56 | 113 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HealthPartners Institute