Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients

Not Applicable

Completed

• Conditions: Sunlight Exposure

• Registration Number: NCT04392986
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-06-14
• Study Completion: 2019-06-21
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• prehypertensive patients
• vitamin D insufficiency
• age 20-45

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Blood pressure	24 hours	24 hour ambulatory blood pressure monitoring
pulse rate	24 hours

Secondary Outcome Measures

Name	Time	Method
Height	3 weeks	Height in meters
25-hydroxyvitamin D3	3 weeks	ng/mL
Norepinephrine	3 weeks	pg/mL
Weight	3 weeks	Weight in kilograms
Aldosterone	3 weeks	ng/mL
Age	3 weeks	Age in years
ACTH	3 weeks	pg/mL

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of