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Completed

NCT Number: NCT03310242

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sunlight Exposure

Behavioral
  • Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
  • Completing a Sun Diary after sunlight exposure

Vitamin D Supplementation

Dietary Supplement
  • Supplementation of vitamin D3 500 IU/day for 8 weeks

Placebo

Other
  • Intake of placebo for 8 weeks

Primary outcomes

  1. Serum 25(OH)D

    Time frame: Baseline, 4 week, and 8 week

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2017
Registry last updated
Oct 31, 2017

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.

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