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Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels

Primary Purpose

Vitamin D Deficiency, Cardiometabolic Risk Factors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sunlight Exposure
Vitamin D Supplementation
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Serum 25(OH)vitamin D < 12ng/mL
  • age between 18 and 39 years
  • Korean men and women

Exclusion Criteria:

  • Vitamin D supplementation within 2 months
  • Photosensitivity or UV allergy
  • History of hyperparathyroidism/hypercalciuria/kidney stone/skin cancer and other cancer
  • Under medication for hypertension, dyslipidemia, and diabetes
  • Intake of photosensitive medicine during study period
  • Exposure of strong UV (e.g., beach, sun tanning) during study period
  • Pregnant/breast-feeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Sunlight Exposure

    Vitamin D Supplementation

    Placebo

    Arm Description

    Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks

    Supplementation of vitamin D3 500 IU/day for 8 weeks

    Intake of placebo for 8 weeks

    Outcomes

    Primary Outcome Measures

    Serum 25(OH)D
    Changes in serum 25(OH)D levels in ng/mL

    Secondary Outcome Measures

    BMI
    Weight and height will be combined to report BMI in kg/m^2
    Systolic blood pressure
    Systolic blood pressure changes in mmHg
    Diastolic blood pressure
    Diastolic blood pressure changes in mmHg
    Lipid panel
    Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
    Fasting glucose
    Serum fasting glucose in mg/dL
    AST
    Serum AST levels in mg/dL
    ALT
    Serum ALT levels in mg/dL
    GGT
    Serum AST, ALT, and GGT levels in mg/dL
    Intact PTH
    Serum intact PTH levels in mg/dL
    Whole body BMD and BMC
    Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA
    Lean body mass, fat mass, and percent fat
    Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA
    Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
    Lean body mass (kg), muscle mass (kg), skeletal muscle mass (kg), fat mass (kg), and percent fat (%) measured by body impedance analysis
    EQ-5D-5L
    Quality of life measured using EQ-5D-5L scale. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health status. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. The 5-level version of EQ-5D (EQ-5D-5L) was developed to improve such constraints of the three-level scale. EQ-5D-5L scale can define 3,125 (=5^5) different health states, and the 5-digit number can be converted into a preference weight which is also referred to as a single weighted index score. The index score of a value set derived from the general population sample can be regarded as a "societal valuation of the respondent's health state" in that country.

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    October 29, 2017
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03310242
    Brief Title
    Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
    Official Title
    Comparison of Sunlight Exposure and Oral Vitamin D Supplementation on Serum 25-hydroxyvitamin D Concentration and Metabolic Markers in Korean Young Adults: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    November 25, 2015 (Actual)
    Study Completion Date
    November 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to compare the effects between sunlight exposure and oral vitamin D supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean young adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Cardiometabolic Risk Factors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sunlight Exposure
    Arm Type
    Experimental
    Arm Description
    Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
    Arm Title
    Vitamin D Supplementation
    Arm Type
    Experimental
    Arm Description
    Supplementation of vitamin D3 500 IU/day for 8 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Intake of placebo for 8 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sunlight Exposure
    Intervention Description
    Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks Completing a Sun Diary after sunlight exposure
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D Supplementation
    Intervention Description
    - Supplementation of vitamin D3 500 IU/day for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    - Intake of placebo for 8 weeks
    Primary Outcome Measure Information:
    Title
    Serum 25(OH)D
    Description
    Changes in serum 25(OH)D levels in ng/mL
    Time Frame
    Baseline, 4 week, and 8 week
    Secondary Outcome Measure Information:
    Title
    BMI
    Description
    Weight and height will be combined to report BMI in kg/m^2
    Time Frame
    Baseline, 4 week, and 8 week
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure changes in mmHg
    Time Frame
    Baseline, 4 week, and 8 week
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure changes in mmHg
    Time Frame
    Baseline, 4 week, and 8 week
    Title
    Lipid panel
    Description
    Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    Fasting glucose
    Description
    Serum fasting glucose in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    AST
    Description
    Serum AST levels in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    ALT
    Description
    Serum ALT levels in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    GGT
    Description
    Serum AST, ALT, and GGT levels in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    Intact PTH
    Description
    Serum intact PTH levels in mg/dL
    Time Frame
    Baseline and 8 week
    Title
    Whole body BMD and BMC
    Description
    Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA
    Time Frame
    Baseline and 8 week
    Title
    Lean body mass, fat mass, and percent fat
    Description
    Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA
    Time Frame
    Baseline and 8 week
    Title
    Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
    Description
    Lean body mass (kg), muscle mass (kg), skeletal muscle mass (kg), fat mass (kg), and percent fat (%) measured by body impedance analysis
    Time Frame
    Baseline, 4 week, and 8 week
    Title
    EQ-5D-5L
    Description
    Quality of life measured using EQ-5D-5L scale. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health status. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. The 5-level version of EQ-5D (EQ-5D-5L) was developed to improve such constraints of the three-level scale. EQ-5D-5L scale can define 3,125 (=5^5) different health states, and the 5-digit number can be converted into a preference weight which is also referred to as a single weighted index score. The index score of a value set derived from the general population sample can be regarded as a "societal valuation of the respondent's health state" in that country.
    Time Frame
    Baseline, 4 week, and 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Serum 25(OH)vitamin D < 12ng/mL age between 18 and 39 years Korean men and women Exclusion Criteria: Vitamin D supplementation within 2 months Photosensitivity or UV allergy History of hyperparathyroidism/hypercalciuria/kidney stone/skin cancer and other cancer Under medication for hypertension, dyslipidemia, and diabetes Intake of photosensitive medicine during study period Exposure of strong UV (e.g., beach, sun tanning) during study period Pregnant/breast-feeding women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee-Kyung Joh, PhD
    Organizational Affiliation
    Seoul National University College of Medicine/Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30987813
    Citation
    Joh HK, Hwang SS, Cho B, Lim CS, Jung SE. Effect of sun exposure versus oral vitamin D supplementation on serum 25-hydroxyvitamin D concentrations in young adults: A randomized clinical trial. Clin Nutr. 2020 Mar;39(3):727-736. doi: 10.1016/j.clnu.2019.03.021. Epub 2019 Mar 21.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels

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