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

July 15, 2016 updated by: Iris BENZIE, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
vitamin D supplementation group (2500 IU day for 3 months)
Dietary supplement: Vitamin D
2400 units per day for 3 months
Other Names:
  • cholecalciferol
Placebo Comparator: Control
no vitamin D supplementation
Dietary supplement: Vitamin D
2400 units per day for 3 months
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biomarkers of oxidative stress
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Iris F Benzie, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vit D Study part 2 v.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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