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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Control

Arm Description

vitamin D supplementation group (2500 IU day for 3 months)

no vitamin D supplementation

Outcomes

Primary Outcome Measures

biomarkers of oxidative stress

Secondary Outcome Measures

Full Information

First Posted
May 20, 2015
Last Updated
July 15, 2016
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02451787
Brief Title
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2
Official Title
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
vitamin D supplementation group (2500 IU day for 3 months)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
no vitamin D supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Description
2400 units per day for 3 months
Primary Outcome Measure Information:
Title
biomarkers of oxidative stress
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris F Benzie, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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