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| ID | Type | Description | Link |
|---|---|---|---|
| SU-09262011-8486 | Other Identifier | Stanford University | |
| BRSADJ0024 | Other Identifier | OnCore |
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Slow accrual
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This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.
Vitamin D3 (cholecalciferol, colecalciferol) is one of type of vitamin D which is made by the skin when exposed to sunlight; it is also found in some foods and can be taken as a dietary supplement. It is used to treat and prevent vitamin D deficiency and associated diseases, including rickets. Vitamin D3 may have a role obesity and cancer biology. In the body, Vitamin D3 is metabolized to the active form 1,25-dihydroxycholecalciferol (calcitriol, 1,25-(OH)2vitamin D3).
This protocol is a randomized, controlled, and blinded clinical trial in obese and non-obese breast cancer patients in whom the effects of vitamin D supplementation will be evaluated in the neoadjuvant setting. Changes in biomarker expression levels in blood will be assessed from baseline to post-treatment (post-surgery).
Per protocol (see title), the treatment groups are defined as those participants with body mass index (BMI) ≤ 25 ("non-obese") and > 25 ("obese"). Within each treatment group, dose of Vitamin D3 was stratified between 400 IU/day (control) and 10,000 IU/day (experimental). All analyses were typically conducted between BMI cohorts stratified by Vitamin D3 dose.
Protocol Primary Objective: "To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non obese subjects diagnosed with breast cancer."
Protocol Secondary Objectives: "To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by serum biomarkers of insulin resistance and adipokine secretion in obese and non obese subjects diagnosed with breast cancer."
The following markers will be part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-obese (Body Mass Index ≤ 25) | Experimental | Non-obese participants receive Vitamin D at 400 or 10,000 IU/day |
|
| Obese (Body Mass Index > 25) | Experimental | Obese participants receive Vitamin D at 400 or 10,000 IU/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene | To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors. Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene | p21 [aka p21Cip1; p21Waf1, cyclin-dependent kinase inhibitor 1 (CDKI1) or cyclin-dependent kinase (CDK)-interacting protein 1 (CDKIP1)] gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Level of MKI67 Gene | Ki 67 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Telli, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Cancer Institute | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-obese (Body Mass Index ≤ 25) | Non-obese participants receive Vitamin D at 400 or 10,000 IU/day |
| FG001 | Obese (Body Mass Index > 25) | Obese participants receive Vitamin D at 400 or 10,000 IU/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-obese (Body Mass Index ≤ 25) | Non-obese participants receive Vitamin D at 400 or 10,000 IU/day |
| BG001 | Obese (Body Mass Index > 25) | Obese participants receive Vitamin D at 400 or 10,000 IU/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene | To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors. Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Mean | Standard Deviation | ratio baseline:post-treatment (slope) | up to 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-obese (Body Mass Index ≤ 25) | Non-obese participants receive Vitamin D at 400 or 10,000 IU/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary hyperparathyroidism (HPT) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Telli, Associate Professor of Medicine (Oncology) | Stanford University | 650-724-9533 | mtelli@stanford.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| up to 6 weeks |
| Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene | Matrix metalloproteinase-11 (MMP-11), aka Stromelysin-3 (SL-3), gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | up to 6 weeks |
| up to 6 weeks |
| Expression Level of ESR1 Gene | ESR1 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | up to 6 weeks |
| Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood | Levels in blood of leptin & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day and 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin and adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on both leptin and adiponectin collectively, with a value <1.00 meaning that the effect on leptin levels was reduced relative to the effect on adiponectin levels, and a value >1.00 that the effect on leptin levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 means no measure change). | up to 6 weeks |
| HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood | The Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR) was used to assess fasting insulin & glucose levels. HOMA-IR & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome is for non-obese vs obese participants stratified between 400 & 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome expresses the treatment effect on HOMA-IR & adiponectin collectively, with <1.00 meaning effect on HOMA-IR levels is reduced relative to the effect on adiponectin levels, & >1.00 meaning the effect is increased relative, with a greater difference meaning greater effect (1.00 represents no measure change). | up to 6 weeks |
| cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood | Levels in blood of cRP (C-reactive protein) & adiponectin were assessed at baseline & after treatment in participants with body mass index (BMI) ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day & 10,000 IU/day. For all serum protein levels, the outcome is the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on cRP and adiponectin collectively, with a value < 1.00 meaning effect on cRP levels was reduced relative to the effect on adiponectin levels, and a value > 1.00 meaning effect on cRP levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 represents no measure change). | up to 6 weeks |
| Pharmacokinetics of Vitamin D Metabolite Calcitriol | Blood levels (pharmacokinetics) of Vitamin D were evaluated as the blood levels of Vitamin D metabolite calcitriol (also known as 1,25-dihydroxycholecalciferol or 1,25(OH)2D) in participants receiving 400 IU/day Vitamin D. The outcome is reported as the mean calcitriol level pre-treatment and post-treatment, with standard deviation. | up to 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Non-obese (Body Mass Index ≤ 25) | Non-obese participants receive Vitamin D at 400 or 10,000 IU/day |
| OG001 | Obese (Body Mass Index > 25) | Obese participants receive Vitamin D at 400 or 10,000 IU/day |
|
|
| Secondary | Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene | p21 [aka p21Cip1; p21Waf1, cyclin-dependent kinase inhibitor 1 (CDKI1) or cyclin-dependent kinase (CDK)-interacting protein 1 (CDKIP1)] gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Mean | Standard Deviation | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Secondary | Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene | Matrix metalloproteinase-11 (MMP-11), aka Stromelysin-3 (SL-3), gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Mean | Standard Deviation | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | Expression Level of MKI67 Gene | Ki 67 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Mean | Standard Deviation | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | Expression Level of ESR1 Gene | ESR1 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Mean | Standard Deviation | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood | Levels in blood of leptin & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day and 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin and adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on both leptin and adiponectin collectively, with a value <1.00 meaning that the effect on leptin levels was reduced relative to the effect on adiponectin levels, and a value >1.00 that the effect on leptin levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 means no measure change). | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Number | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood | The Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR) was used to assess fasting insulin & glucose levels. HOMA-IR & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome is for non-obese vs obese participants stratified between 400 & 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome expresses the treatment effect on HOMA-IR & adiponectin collectively, with <1.00 meaning effect on HOMA-IR levels is reduced relative to the effect on adiponectin levels, & >1.00 meaning the effect is increased relative, with a greater difference meaning greater effect (1.00 represents no measure change). | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Number | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood | Levels in blood of cRP (C-reactive protein) & adiponectin were assessed at baseline & after treatment in participants with body mass index (BMI) ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day & 10,000 IU/day. For all serum protein levels, the outcome is the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on cRP and adiponectin collectively, with a value < 1.00 meaning effect on cRP levels was reduced relative to the effect on adiponectin levels, and a value > 1.00 meaning effect on cRP levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 represents no measure change). | Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level. | Posted | Number | ratio baseline:post-treatment (slope) | up to 6 weeks |
|
|
|
| Other Pre-specified | Pharmacokinetics of Vitamin D Metabolite Calcitriol | Blood levels (pharmacokinetics) of Vitamin D were evaluated as the blood levels of Vitamin D metabolite calcitriol (also known as 1,25-dihydroxycholecalciferol or 1,25(OH)2D) in participants receiving 400 IU/day Vitamin D. The outcome is reported as the mean calcitriol level pre-treatment and post-treatment, with standard deviation. | All participants are included. Pharmacokinetics results are provided for non-obese vs obese participants, stratified by dose received, and presented as the pre-treatment and post-treatment pharmacokinetic values. | Posted | Mean | Standard Deviation | ng/mL | up to 6 weeks | Samples for this dose & time | Samples for this dose & time |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Obese (Body Mass Index > 25) | Obese participants receive Vitamin D at 400 or 10,000 IU/day | 0 | 16 | 1 | 16 | 1 | 16 |
| Neuroendocrine cancer of the breast, metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Plasma chromogranin A level, elevated | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Vitamin D 10,000 IU/day |
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| Vitamin D 10,000 IU/day |
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| Vitamin D 10,000 IU/day |
|
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| Vitamin D 10,000 IU/day |
|
|
| Vitamin D 10,000 IU/d |
|
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| Vitamin D 10,000 IU/day |
|
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| Vitamin D 10,000 IU/day |
|
|
|
| Pre-treatment, 10,000 IU/day |
|
|
| Post-treatment, 400 IU/day |
|
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| Post-treatment, 10,000 IU/day |
|
|