Trial Outcomes & Findings for hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects (NCT NCT00742235)

NCT ID: NCT00742235

Last Updated: 2016-04-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2016-04-14

Participant Flow

Healthy subjects were recruited via flyer to a clinical research center.

Subjects were excluded for eGFR<60, hypercalcemia, history of nephrolithiasis.

Participant milestones

Measure	Vitamin D Sufficient Subjects not treated with ergocalciferol and who had 25-OH vitamin D \> 32 ng/ml.	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)
Overall Study STARTED	32	67
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	0	31

Reasons for withdrawal

Measure	Vitamin D Sufficient Subjects not treated with ergocalciferol and who had 25-OH vitamin D \> 32 ng/ml.	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)
Overall Study Lost to Follow-up	0	31

Baseline Characteristics

hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Baseline characteristics by cohort

Measure	Vitamin D Sufficient n=32 Participants Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	Vitamin D Insufficient n=67 Participants 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.	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	66 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 14.9 • n=5 Participants	36.7 years STANDARD_DEVIATION 12.5 • n=7 Participants	36.5 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	37 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	67 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Vitamin D Sufficient n=29 Participants Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	Vitamin D Insufficient n=65 Participants 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.
hCAP18 Levels	762 ng/ml Standard Deviation 347	639 ng/ml Standard Deviation 286

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Vitamin D Sufficient n=32 Participants Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	Vitamin D Insufficient n=67 Participants 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.
Baseline 25-OH Vitamin D Level	40 ng/ml Interval 40.0 to 51.5	25 ng/ml Interval 20.0 to 29.0

Adverse Events

Vitamin D Sufficient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D Insufficient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Massachusetts General Hospital

Phone: 617-726-3934

Email: ibhan@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place