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The purpose of this project is to demonstrate the capability of a standing phototherapy kiosk (SPK) to stimulate cutaneous vitamin D3 and subsequent production of 25 Hydroxyvitamin (OH) D safely and as efficiently as an oral vitamin D3 supplement of 600 IU taken daily over a 10 week intervention period. We will conduct a randomized controlled trial with two treatment arms; ~120 volunteers will be assigned to either the SPK or to a 600 IU daily oral vitamin D3 supplement for 10 weeks. The SPK is an innovative, networked, self-care technology that stimulates endogenous vitamin D production with two ~2-minute treatments per month. It will be tested in an ambulatory setting where enrolled/assigned participants of various baseline levels of 25(OH)D will present for a treatment dose, based on Fitzpatrick skin type category, every other week for 10 weeks. The SPK does not produce a cosmetic tan or dispense pills.
The proposed pilot study uses a prospective, longitudinal, randomized design with repeated measures to address vitamin D sufficiency in Active Duty (AD), retiree, beneficiary, and Department of Army civilian populations. It is important and necessary to conduct this study with adult humans, military personnel in particular, to determine acceptability and feasibility of this phototherapy kiosk as an addition to existing Warfighter resources to promote health and resilience. Anticipating 20% attrition, approximately 120 volunteers will be recruited from Madigan Army Medical Center and Joint Base Lewis-McChord (JBLM), a large joint base in the Pacific Northwest, where over 25,000 Soldiers and Airmen train every day and regional beneficiaries number ~98,000. Recruiting efforts will attempt to capture a representative sample of the population including genders, diverse ethnicities, and a range of age (18-70 years) and body mass index, who have no contraindication for Ultraviolet (UV) B exposure or oral vitamin D supplementation. Using a computer-generated block design, volunteers will be randomized to one of two treatment groups; 1) oral vitamin D supplementation, or 2) standing phototherapy kiosk (SPK) with UVB exposure, for a 10 week period.
Group 1- Supplement: A Madigan Army Medical Center (MAMC) Research Pharmacist will dispense a 10-week supply of the vitamin D3 600 International Units (IU) oral supplement to subjects assigned to this group one time. The Project Coordinator will work with the pharmacist to coordinate pick-up of supplement bottles for subjects or optimal in-person dispensing times.
Group 2 - SPK: The Project Coordinator will oversee the phototherapy treatment. Spectrum isolation modules in the kiosk will deliver the UVB dose under supervised conditions over a 2-5 minute interval based on the Fitzpatrick skin type category with the subject wearing minimal or no clothing, preferably no more than a bathing suit and protective eye-wear. The experience in the SPK is designed to be comfortable.
We will enroll all eligible adult volunteers regardless of their baseline 25(OH)D level; it is important to show there is no potential for harm from phototherapy, even if the baseline 25(OH)D level is above 30 ng/mL. We also must learn the trajectory of vitamin D absorption and availability over a 3-4 month period in order to make evidence-based therapeutic recommendations. It is not possible to blind the subjects or research team to the group assignment. Serum levels of 25(OH)D, calcium, and parathyroid hormone will be drawn at baseline (T0), and immediately following the intervention at 10 weeks (T6); at 14 weeks (T8), 25(OH) D will be drawn to document sustainment of treatment effect. A survey will be completed at T1 to capture relevant demographic, medical history, sun exposure, travel, daily activities, and dietary data. Active duty participants will also report the number of days on profile for the previous three months, at T1 and T6. A survey regarding Device Usability will be administered upon kiosk protocol completion. We will analyze data using repeated measures analysis of variance adjusting for significant covariates such as 25(OH)D level at baseline. Logistic regression analyses will be used to predict outcomes and explain the interrelationships among variables, i.e. age, gender, body fat, BMI, ethnicity, and sun exposure relationship to 25(OH)D serum levels.
Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standing Phototherapy Kiosk (SPK) | Experimental | Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. |
|
| Oral Supplement | Active Comparator | Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standing Phototherapy Kiosk | Device | Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Vitamin D Level | 25 Hydroxyvitamin D level in the blood | 10 weeks |
| Change in Serum Vitamin D Level From Baseline to Week 14 | Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group. | Baseline and 14 weeks |
| Percentage of Participants With Adherence | Percentage of participants with adherence to daily supplement, and Percentage of phototherapy treatments received. Adherence to daily supplement was calculated as the percentage of participants who consumed all 70 pills. Adherence to phototherapy treatments was calculated as the percentage of participants who received all 6 treatments according to protocol. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device Acceptability Using Device Usability Scale | User acceptability and satisfaction with the novel kiosk on the Device Usability Scale (DUS), also referred to as System Usability Scale. The DUS was administered to the SPK Group upon completion of the study to assess user acceptability of the intervention. This 12-item Likert-type scale assessed cleanliness, ease of use, and comfort of the kiosk with a Likert-type scale where 1= Strongly disagree to 5 = Strongly agree. Minimum score = 12, maximum score = 60. Higher scores indicate greater acceptability and satisfaction with the device. |
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Inclusion Criteria:
Exclusion Criteria:
anti-seizure medications, cyclosporine, indinavir (Crixivan) • Adults diagnosed with light allergies: Actinic prurigo, Polymorphous light eruption, Solar urticaria
• Adults diagnosed with light sensitivities: Protoporphyria, Photodermatitis, Xeroderma pigmentosum, Lupus erythematosus, Actinic dermatitis, UV-sensitive syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Mary S McCarthy, PhD | Nurse Scientist, CNSCI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11729127 | Background | Koutkia P, Lu Z, Chen TC, Holick MF. Treatment of vitamin D deficiency due to Crohn's disease with tanning bed ultraviolet B radiation. Gastroenterology. 2001 Dec;121(6):1485-8. doi: 10.1053/gast.2001.29686. | |
| 26853300 | Background | He CS, Aw Yong XH, Walsh NP, Gleeson M. Is there an optimal vitamin D status for immunity in athletes and military personnel? Exerc Immunol Rev. 2016;22:42-64. |
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No pre-assignment activities.
Recruiting efforts attempted to capture a representative sample of the population including both genders, diverse ethnicities, and a range of age (18-70 years) and BMI, who have no contraindication for UVB exposure or oral vitamin D supplementation. In addition to walk-in volunteers who read medical center flyers or social media posts, or were informed through word-of-mouth, the team attended the military base Newcomer's Orientation monthly. Recruitment period 8 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standing Phototherapy Kiosk (SPK) | Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway. |
| FG001 | Oral Supplement | Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standing Phototherapy Kiosk (SPK) | Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway. |
| 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 | Serum Vitamin D Level | 25 Hydroxyvitamin D level in the blood | Final sample included 43 in SPK and 45 in Oral Supplement group; 10 subjects of 98 enrolled dropped out prior to the end of the study. | Posted | Median | Inter-Quartile Range | ng/mL | 10 weeks |
|
The study was 11 months in length.
Participants in the Phototherapy group were asked to report skin reactions (eg sunburn) due to exposure from the phototherapy kiosk. Erythema events that resembled an E3 or E4 as characterized in "Chapter 5 of Radiation dosimetry: physical and biological aspects" were defined as adverse events. In the Supplement group, taking more of the D3 supplement than prescribed could be harmful.
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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 | Standing Phototherapy Kiosk (SPK) | Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk. Standing Phototherapy Kiosk: Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway. |
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Due to the use of an untested device, the appropriate sample size was estimated based on previous and current vitamin D studies, involving an adult population, and a similar approach to vitamin D supplementation. Study conducted at a single center in a geographic location known for limited opportunity for exposure to UVB as a source for vitamin D therefore low vitamin D status is common. Results may not be generalizable to adults in communities throughout the US.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary McCarthy | Madigan Army Medical Center | 253-968-3695 | mary.s.mccarthy1.civ@health.mil |
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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 | Jun 27, 2017 | Jan 12, 2024 | Prot_SAP_001.pdf |
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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 |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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For volunteers assigned to the phototherapy kiosk, a measured dose of UVB was administered under conditions of full body exposure of 0.6 minimal erythemal dose (MED) every other week for 10 weeks. The stimulation of cutaneous vitamin D and subsequent 25(OH)D production from phototherapy was compared to the effect of a Recommended Daily Allowance (RDA) based dose of 600 IU vitamin D3 supplement daily for 10 weeks.
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A computer-generated block design was created by an onsite biostatistician and used by the research pharmacist to randomize subjects. Once a subject met the inclusion criteria, the pharmacist was notified and she relayed the group assignment to the Project Coordinator. The study team had no knowledge of the group assignment in advance.
|
|
| D3 Oral supplement | Dietary Supplement | Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment. |
|
|
| 14 weeks |
| Number of Subjects Retained at 14 Weeks | We examined the number of subjects remaining at 14 weeks. | Baseline to 14 weeks |
| 21646368 | Background | Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. |
| 17254541 | Background | Chen TC, Chimeh F, Lu Z, Mathieu J, Person KS, Zhang A, Kohn N, Martinello S, Berkowitz R, Holick MF. Factors that influence the cutaneous synthesis and dietary sources of vitamin D. Arch Biochem Biophys. 2007 Apr 15;460(2):213-7. doi: 10.1016/j.abb.2006.12.017. Epub 2007 Jan 8. |
| 3377516 | Background | Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. |
| 22013924 | Background | Bogh MK, Schmedes AV, Philipsen PA, Thieden E, Wulf HC. A small suberythemal ultraviolet B dose every second week is sufficient to maintain summer vitamin D levels: a randomized controlled trial. Br J Dermatol. 2012 Feb;166(2):430-3. doi: 10.1111/j.1365-2133.2011.10697.x. |
| Withdrawal by Subject |
|
| BG001 | Oral Supplement | Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Attrition resulted in the loss of 10 participants from the Kiosk Group and 8 participants from the Oral Supplement Group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Attrition resulted in the loss of 8 participants from the Oral Supplement Grp and 10 participants from the Kiosk Grp. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Due to attrition, the number analyzed is different from the number enrolled. | Count of Participants | Participants |
|
| Region of Enrollment | Due to attrition, the number analyzed differs from the number enrolled. | Number | participants |
|
| Marital status | Marital status obtained via demographic questionnaire; subject was asked whether he/she was single or married. | Due to attrition, the number of subjects analyzed differs from the number enrolled. | Count of Participants | Participants |
|
| Military affiliation | Subjects answered the question of military affiliation as active duty, retired or former service member, family member, none. | Due to attrition, the number of subjects analyzed differs from the number enrolle. | Count of Participants | Participants |
|
| OG001 | Oral Supplement | Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment. |
|
|
|
| Primary | Change in Serum Vitamin D Level From Baseline to Week 14 | Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group. | Final sample included 43 in SPK group and 45 in Oral supplement group; 10 of 98 dropped out | Posted | Median | Inter-Quartile Range | ng/mL | Baseline and 14 weeks |
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|
|
| Primary | Percentage of Participants With Adherence | Percentage of participants with adherence to daily supplement, and Percentage of phototherapy treatments received. Adherence to daily supplement was calculated as the percentage of participants who consumed all 70 pills. Adherence to phototherapy treatments was calculated as the percentage of participants who received all 6 treatments according to protocol. | Intent-to-treat analysis used to assess number consuming all of the Oral supplement and the number receiving all 6 phototherapy (SPK) treatments. | Posted | Number | percentage of participants | 10 weeks |
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|
|
| Secondary | Device Acceptability Using Device Usability Scale | User acceptability and satisfaction with the novel kiosk on the Device Usability Scale (DUS), also referred to as System Usability Scale. The DUS was administered to the SPK Group upon completion of the study to assess user acceptability of the intervention. This 12-item Likert-type scale assessed cleanliness, ease of use, and comfort of the kiosk with a Likert-type scale where 1= Strongly disagree to 5 = Strongly agree. Minimum score = 12, maximum score = 60. Higher scores indicate greater acceptability and satisfaction with the device. | Only the SPK group was asked about acceptability and satisfaction with the kiosk. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
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|
|
| Secondary | Number of Subjects Retained at 14 Weeks | We examined the number of subjects remaining at 14 weeks. | Subject retention at the 14-week measurement point | Posted | Count of Participants | Participants | No | Baseline to 14 weeks |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Oral Supplement | Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. D3 Oral supplement: Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment. | 0 | 53 | 0 | 53 | 0 | 53 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Family member |
|
| None |
|