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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03310242
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Cardiometabolic Risk Factors Behavioral: Sunlight Exposure Dietary Supplement: Vitamin D Supplementation Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : November 25, 2015
Actual Study Completion Date : November 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Sunlight Exposure
Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
Behavioral: Sunlight Exposure
  • Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
  • Completing a Sun Diary after sunlight exposure

Experimental: Vitamin D Supplementation
Supplementation of vitamin D3 500 IU/day for 8 weeks
Dietary Supplement: Vitamin D Supplementation
- Supplementation of vitamin D3 500 IU/day for 8 weeks

Placebo Comparator: Placebo
Intake of placebo for 8 weeks
Other: Placebo
- Intake of placebo for 8 weeks




Primary Outcome Measures :
  1. Serum 25(OH)D [ Time Frame: Baseline, 4 week, and 8 week ]
    Changes in serum 25(OH)D levels in ng/mL


Secondary Outcome Measures :
  1. BMI [ Time Frame: Baseline, 4 week, and 8 week ]
    Weight and height will be combined to report BMI in kg/m^2

  2. Systolic blood pressure [ Time Frame: Baseline, 4 week, and 8 week ]
    Systolic blood pressure changes in mmHg

  3. Diastolic blood pressure [ Time Frame: Baseline, 4 week, and 8 week ]
    Diastolic blood pressure changes in mmHg

  4. Lipid panel [ Time Frame: Baseline and 8 week ]
    Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL

  5. Fasting glucose [ Time Frame: Baseline and 8 week ]
    Serum fasting glucose in mg/dL

  6. AST [ Time Frame: Baseline and 8 week ]
    Serum AST levels in mg/dL

  7. ALT [ Time Frame: Baseline and 8 week ]
    Serum ALT levels in mg/dL

  8. GGT [ Time Frame: Baseline and 8 week ]
    Serum AST, ALT, and GGT levels in mg/dL

  9. Intact PTH [ Time Frame: Baseline and 8 week ]
    Serum intact PTH levels in mg/dL

  10. Whole body BMD and BMC [ Time Frame: Baseline and 8 week ]
    Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA

  11. Lean body mass, fat mass, and percent fat [ Time Frame: Baseline and 8 week ]
    Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA

  12. Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat [ Time Frame: Baseline, 4 week, and 8 week ]
    Lean body mass (kg), muscle mass (kg), skeletal muscle mass (kg), fat mass (kg), and percent fat (%) measured by body impedance analysis

  13. EQ-5D-5L [ Time Frame: Baseline, 4 week, and 8 week ]

    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.




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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03310242


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Kyung Joh, PhD Seoul National University College of Medicine/Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03310242    
Other Study ID Numbers: H-1504-112-668
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents