Healthy Subjects, Vitamin D Deficiency
Conditions
Brief summary
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.
Interventions
DRUGergocalciferol
Ergocalciferol 50,000 IU given every other day for 5 total doses
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-80
Exclusion criteria
* Known active infectious disease or chronic inflammatory disorder * Hypercalcemia * Chronic kidney disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hCAP18 Levels | Baseline |
| Baseline 25-OH Vitamin D Level | Baseline |
Countries
United States
Participant flow
Recruitment details
Healthy subjects were recruited via flyer to a clinical research center.
Pre-assignment details
Subjects were excluded for eGFR\<60, hypercalcemia, history of nephrolithiasis.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Sufficient Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol. | 32 |
| 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. | 67 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 31 |
Baseline characteristics
| Characteristic | Vitamin D Insufficient | Vitamin D Sufficient | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 32 Participants | 98 Participants |
| Age, Continuous | 36.7 years STANDARD_DEVIATION 12.5 | 36.1 years STANDARD_DEVIATION 14.9 | 36.5 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 67 participants | 32 participants | 99 participants |
| Sex: Female, Male Female | 30 Participants | 21 Participants | 51 Participants |
| Sex: Female, Male Male | 37 Participants | 11 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 36 |
| serious Total, serious adverse events | 0 / 0 | 0 / 36 |
Outcome results
Primary
Baseline 25-OH Vitamin D Level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin D Sufficient | Baseline 25-OH Vitamin D Level | 40 ng/ml |
| Vitamin D Insufficient | Baseline 25-OH Vitamin D Level | 25 ng/ml |
Primary
hCAP18 Levels
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Sufficient | hCAP18 Levels | 762 ng/ml | Standard Deviation 347 |
| Vitamin D Insufficient | hCAP18 Levels | 639 ng/ml | Standard Deviation 286 |