A Randomized Trial of Vitamin D to Reduce Respiratory Inf... | NCT01705314

Studies
A Randomized Trial of Vitamin D to Reduce Respiratory Infection

NCT01705314

Sponsor

McMaster University

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

1,300Actual

Phase

Not Applicable

Conditions

Respiratory Infection

Interventions

vitamin D supplements
placebo

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Oct 9, 2012

First Submission Date that Met QC Criteria

Oct 11, 2012

First Posted Date

Oct 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D supplements	Experimental	children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months	Dietary Supplement: vitamin D supplements
vitamin D placebo	Placebo Comparator	children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months	Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D supplements	Dietary Supplement	Participants will receive 7mls of D-drops (14,000U/week of vitamin D)	vitamin D supplements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laboratory-confirmed non-influenza infection		12 months
Laboratory-confirmed influenza infection		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between the ages of 3 and 17
Residing in Thanh Liem District, Ha Nam Province, Vietnam

Exclusion Criteria:

Born prematurely at less than 32 weeks gestation
Any chronic illness (except asthma)
Currently using medication known to interfere with vitamin D metabolism
Children with a sibling participating in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Loeb, MD	McMaster University, Hamilton, ON, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Hygiene and Epidemiology		Hanoi			Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided