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

NCT ID: NCT02451787

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2400 units per day for 3 months

Control

no vitamin D supplementation

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2400 units per day for 3 months

Interventions

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Vitamin D

2400 units per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Iris BENZIE

Chair Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iris F Benzie, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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Vit D Study part 2 v.1

Identifier Type: -

Identifier Source: org_study_id

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