Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
A three-period parallel (baseline, treatment, and post-treatment) design clinical research was conducted. All participants visited a clinical trial center of Korea University Anam Hospital for baseline measurement of clinical variables including ABPM and hematologic biomarkers (ACTH, aldosterone, norepinephrine, cortisol, and 25-hydroxyvitamin D3). After the baseline assessment, participants visited 'Cholipo beach' (Taean, Republic of Korea) for 3 nights and 4 days for the intervention (sunlight exposure program). After a week of wash-out period, post-treatment measurement was processed at Korea University Anam Hospital. Participants were prohibited from vigorous physical activity, alcohol drinking, and smoking during the study period. A normal-sodium diet (2800 mg/day)\[14\], caffeine and smoking restriction was suggested during the whole study period. To control the effect of circadian rhythm on endocrine blood tests and ABPM, we fixed sampling and monitoring start time at 10:00 am. All participants received the same measurements as they did in the baseline measurement during treatment and post-treatment periods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2019
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedMay 19, 2020
May 1, 2020
13 days
May 4, 2020
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Blood pressure
24 hour ambulatory blood pressure monitoring
24 hours
pulse rate
24 hours
Secondary Outcomes (7)
Weight
3 weeks
Height
3 weeks
Age
3 weeks
25-hydroxyvitamin D3
3 weeks
Aldosterone
3 weeks
- +2 more secondary outcomes
Study Arms (2)
Baseline
NO INTERVENTIONBaseline measurement
Intervention
EXPERIMENTALSunlight intervention
Interventions
The weather was sunny and found suitable for outside activity and sunlight exposure program, with a mean temperature of 27.0-28.5 °C, the humidity of 64-80%, and global solar exposure of 1.28 to 2.99 MJ/m2 during treatment.\[15\] Participants were asked to lie on the beach for 45 minutes per day between 2 to 3 pm to avoid extreme skin irritation and sunburn from direct sunlight exposure.
Eligibility Criteria
You may qualify if:
- prehypertensive patients
- vitamin D insufficiency
- age 20-45
You may not qualify if:
- medical comorbidity other than prehypertension
- participant using medication
- Subjects with a history of cardiovascular, renal, hepatic, gastrointestinal, hematologic, psychological, or gastrointestinal abnormalities, taking any kind of medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 19, 2020
Study Start
June 1, 2018
Primary Completion
June 14, 2018
Study Completion
June 21, 2019
Last Updated
May 19, 2020
Record last verified: 2020-05