The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2

Vitamin D Deficiency Clinical Trial

Official title:

The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451787
• Other study ID #: Vit D Study part 2 v.1
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2015
• Last updated: July 15, 2016
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

The investigators major aims are to: determine the vitamin D status of a group of young, apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial health; and, in part 2 of the study, investigate effects of improvement in vitamin D status on these biomarkers and other measures of well-being in those young adults shown to be deficient in vitamin D.

Description:

In this part 2 of the study the investigators will investigate the effect of vitamin D supplementation on biomarkers of these 'hidden' changes in apparently healthy young adults. The investigators will also explore the effect of improvement in vitamin D status in young apparently healthy adults in regard to muscular strength and response time, glucose control, a hormone that is linked to vitamin D (parathyroid hormone (PTH) ) and mood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• apparently healthy, non-smokers

• non-obese

• found (in part1) to have low vitamin D status

Exclusion Criteria:

• chronic illness

• serious illness requiring medical treatment in previous 6 months

• pregnancy

• on regular medication or taking supplements on a regular basis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
2400 units per day for 3 months

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomarkers of oxidative stress		3 months	No