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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310242
• Other study ID #: H-1504-112-668
• Status: Completed
• Phase: N/A
• First received: July 31, 2017
• Last updated: October 29, 2017
• Start date: June 1, 2015
• Est. completion date: November 30, 2015

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2015
• Est. primary completion date: November 25, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors
• Vitamin D Deficiency

Intervention

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

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

Other:
• Placebo
- Intake of placebo for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D	Changes in serum 25(OH)D levels in ng/mL	Baseline, 4 week, and 8 week
Secondary	BMI	Weight and height will be combined to report BMI in kg/m^2	Baseline, 4 week, and 8 week
Secondary	Systolic blood pressure	Systolic blood pressure changes in mmHg	Baseline, 4 week, and 8 week
Secondary	Diastolic blood pressure	Diastolic blood pressure changes in mmHg	Baseline, 4 week, and 8 week
Secondary	Lipid panel	Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL	Baseline and 8 week
Secondary	Fasting glucose	Serum fasting glucose in mg/dL	Baseline and 8 week
Secondary	AST	Serum AST levels in mg/dL	Baseline and 8 week
Secondary	ALT	Serum ALT levels in mg/dL	Baseline and 8 week
Secondary	GGT	Serum AST, ALT, and GGT levels in mg/dL	Baseline and 8 week
Secondary	Intact PTH	Serum intact PTH levels in mg/dL	Baseline and 8 week
Secondary	Whole body BMD and BMC	Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA	Baseline and 8 week
Secondary	Lean body mass, fat mass, and percent fat	Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA	Baseline and 8 week
Secondary	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	Baseline, 4 week, and 8 week
Secondary	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.	Baseline, 4 week, and 8 week