hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00742235
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Vitamin D Deficiency	Drug: ergocalciferol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)	Drug: ergocalciferol; Ergocalciferol 50,000 IU given every other day for 5 total doses; Other Names: Vitamin D
No Intervention: Vitamin D sufficient Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml

Outcome Measures

Primary Outcome Measures

1. hCAP18 Levels [Baseline]

2. Baseline 25-OH Vitamin D Level [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18-80

Exclusion Criteria:

• Known active infectious disease or chronic inflammatory disorder

• Hypercalcemia

• Chronic kidney disease

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Ishir Bhan, MD MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ishir Bhan, MD, MPH, Instructor in Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00742235
• Other Study ID Numbers: 2008-P-0003000/1
• First Posted: Aug 27, 2008
• Last Update Posted: Apr 14, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D; Ergocalciferols

Study Results

Participant Flow

Recruitment Details	Healthy subjects were recruited via flyer to a clinical research center.
Pre-assignment Detail	Subjects were excluded for eGFR<60, hypercalcemia, history of nephrolithiasis.

Arm/Group Title	Vitamin D Sufficient	Vitamin D Insufficient
Arm/Group Description	Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.	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)
Period Title: Overall Study
STARTED	32	67
COMPLETED	32	36
NOT COMPLETED	0	31

Baseline Characteristics

Arm/Group Title	Vitamin D Sufficient	Vitamin D Insufficient	Total
Arm/Group Description	Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	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 of all reporting groups
Overall Participants	32	67	99
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	66 98.5%	98 99%
>=65 years	0 0%	1 1.5%	1 1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.1 (14.9)	36.7 (12.5)	36.5 (13.3)
Sex: Female, Male (Count of Participants)
Female	21 65.6%	30 44.8%	51 51.5%
Male	11 34.4%	37 55.2%	48 48.5%
Region of Enrollment (participants) [Number]
United States	32 100%	67 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	hCAP18 Levels
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D Sufficient	Vitamin D Insufficient
Arm/Group Description	Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	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.
Measure Participants	29	65
Mean (Standard Deviation) [ng/ml]	762 (347)	639 (286)

2. Primary Outcome

Title	Baseline 25-OH Vitamin D Level
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D Sufficient	Vitamin D Insufficient
Arm/Group Description	Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.	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.
Measure Participants	32	67
Median (Inter-Quartile Range) [ng/ml]	40	25

Adverse Events

Arm/Group Title	Vitamin D Sufficient		Vitamin D Insufficient
Arm/Group Description	Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.		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.
All Cause Mortality
	Vitamin D Sufficient		Vitamin D Insufficient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vitamin D Sufficient		Vitamin D Insufficient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin D Sufficient		Vitamin D Insufficient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.