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Difficulty with study logistics due to COVID-19
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The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men-Calcitriol | Active Comparator | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. |
|
| Premenopausal Women-Calcitriol | Active Comparator | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. |
|
| Men-Placebo | Placebo Comparator | 0.25mcg capsule daily for eight weeks |
|
| Premenopausal Women-Placebo | Placebo Comparator | 0.25mcg capsule daily for eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol capsules | Drug | 0.25micrograms, taken daily for eight weeks, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Levels | Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Baseline and 8 weeks |
| Insulin Level | Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Baseline and 8 weeks |
| C-Peptide Level | Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS 10 Questionnaire | Brief 10 question multiple choice survey | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Menopausal status is of interest to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Kumar, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Men-Calcitriol | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally |
| FG001 | Premenopausal Women-Calcitriol | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally |
| FG002 | Men-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
| FG003 | Premenopausal Women-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Men-Calcitriol | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally |
| BG001 | Premenopausal Women-Calcitriol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Glucose Levels | Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Data not collected or analyzed at 8 weeks for the one participant in the Premenopausal Women-Placebo study arm. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.
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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 | Men-Calcitriol | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep ache medial and lateral parapatellar region | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajiv Kumar, MD | Mayo Clinic | 507-284-0020 | rkumar@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2000 | Dec 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Oral Placebo | Drug | Placebo will be created to mimic the appearance of the study drug |
|
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally
| BG002 | Men-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
| BG003 | Premenopausal Women-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally
| OG002 | Men-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
| OG003 | Premenopausal Women-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug |
|
|
| Primary | Insulin Level | Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Posted | Mean | Standard Deviation | uIU/mL | Baseline and 8 weeks |
|
|
|
| Primary | C-Peptide Level | Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. | Posted | Mean | Standard Deviation | nmol/L | Baseline and 8 weeks |
|
|
|
| Secondary | PROMIS 10 Questionnaire | Brief 10 question multiple choice survey | Data not collected or analyzed | Posted | 8 weeks |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Premenopausal Women-Calcitriol | Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Men-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Premenopausal Women-Placebo | 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug | 0 | 4 | 0 | 4 | 0 | 4 |
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| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Title | Measurements |
|---|---|
|
| 8 Weeks |
|
| 8 Weeks |
|