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Completed

NCT Number: NCT04392986

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

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunlight exposure

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.

Primary outcomes

  1. Blood pressure

    Time frame: 24 hours

    24 hour ambulatory blood pressure monitoring

  2. pulse rate

    Time frame: 24 hours

Secondary outcomes

  1. Weight

    Time frame: 3 weeks

    Weight in kilograms

  2. Height

    Time frame: 3 weeks

    Height in meters

  3. Age

    Time frame: 3 weeks

    Age in years

  4. 25-hydroxyvitamin D3

    Time frame: 3 weeks

    ng/mL

  5. Aldosterone

    Time frame: 3 weeks

    ng/mL

  6. Norepinephrine

    Time frame: 3 weeks

    pg/mL

  7. ACTH

    Time frame: 3 weeks

    pg/mL

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.