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

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ClinicalTrials.gov Identifier: NCT04392986
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ji-Young Park, Korea University Anam Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sunlight Exposure Other: Sunlight exposure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group parallel study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Baseline
Baseline measurement
Experimental: Intervention
Sunlight intervention
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 24 hours ]
    24 hour ambulatory blood pressure monitoring

  2. pulse rate [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392986


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Anam Hospital
More Information
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Responsible Party: Ji-Young Park, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT04392986    
Other Study ID Numbers: 2018AN0153
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No