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Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses) |
|
| Vitamin D sufficient | No Intervention | Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergocalciferol | Drug | Ergocalciferol 50,000 IU given every other day for 5 total doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| hCAP18 Levels | Baseline | |
| Baseline 25-OH Vitamin D Level | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ishir Bhan, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Subjects were excluded for eGFR<60, hypercalcemia, history of nephrolithiasis.
Healthy subjects were recruited via flyer to a clinical research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Sufficient | Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml. |
| FG001 | Vitamin D Insufficient | Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D Sufficient | Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol. |
| BG001 | Vitamin D Insufficient | Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies. |
| 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 | hCAP18 Levels | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
|
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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 | Vitamin D Sufficient | Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Massachusetts General Hospital | 617-726-3934 | ibhan@partners.org |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
|
| Participants |
|
|
| Primary | Baseline 25-OH Vitamin D Level | Posted | Median | Inter-Quartile Range | ng/ml | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Vitamin D Insufficient | Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies. | 0 | 36 | 0 | 36 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |