NCT02451787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

May 20, 2015

Last Update Submit

July 15, 2016

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • biomarkers of oxidative stress

    3 months

Study Arms (2)

Active

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Control

PLACEBO COMPARATOR

no vitamin D supplementation

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

2400 units per day for 3 months

Also known as: cholecalciferol
ActiveControl

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • apparently healthy, non-smokers
  • non-obese
  • found (in part1) to have low vitamin D status

You may not qualify if:

  • chronic illness
  • serious illness requiring medical treatment in previous 6 months
  • pregnancy
  • on regular medication or taking supplements on a regular basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Iris F Benzie, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 18, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)