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

NCT ID: NCT04392986

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-06-21

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.

Conditions

Sunlight Exposure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Baseline

Baseline measurement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Sunlight intervention

Group Type: EXPERIMENTAL

Sunlight exposure

Intervention Type: OTHER

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.

Interventions

Sunlight exposure

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Young Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2018AN0153

Identifier Type: -

Identifier Source: org_study_id