Condition category
Musculoskeletal Diseases
Date applied
07/02/2007
Date assigned
27/03/2007
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Athena Papas

ORCID ID

Contact details

Tufts University School of Dental Medicine
One Kneeland Street
Room 508
Boston
02111
United States of America
+1 617 636 3931
athena.papas@tufts.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Use of omega-3 supplements can increase oral and ocular comfort and increase salivary flow in Sjogren's patients.

Ethics approval

Ethics approval received from the Institutional Review Board - Tufts University Health Sciences/Tufts - New England Medical Center on the 16th May 2005 (ref: 7370)

Study design

Prospective, randomised, placebo-controlled, double-masked clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Sjogren's syndrome

Intervention

Use of an omega-3 supplement (TheraTears Nutrition, Advanced Vision Research, USA) containing 750 mg of long-chain omega-3s (450 mg of eicosapentaenoic acid [EPA] and 300 mg of docosahexaenoic acid [DHA]) and 1000 mg of flaxseed oil designed to suppress inflammation and increase tear and saliva production.

The participants in the intervention group took the supplement once a day for 3 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Increased oral and ocular comfort at 3 months

Secondary outcome measures

Increased salivary flow and improvement in gingival index (GI) at 3 months

Overall trial start date

07/07/2005

Overall trial end date

04/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with Sjogren's syndrome as defined by the European Criteria and a positive blood test or lip biopsy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

65

Participant exclusion criteria

1. Had less than 10 teeth
2. Received periodontal therapy in the past 12 months or antibiotic therapy in the past 1 month
3. Required pre-medication with antibiotics
4. Had advanced periodontitis, an infectious or wasting disease
5. Already supplementing with omega-3s
6. Participating in another clinical trial

Recruitment start date

07/07/2005

Recruitment end date

04/09/2007

Locations

Countries of recruitment

United States of America

Trial participating centre

Tufts University School of Dental Medicine
Boston
02111
United States of America

Sponsor information

Organisation

Advanced Vision Research (USA)

Sponsor details

660 Main St.
1st Floor
Woburn
Massachusetts
01801
United States of America
+1 800 231 3316
jgilbard@theratears.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Advanced Vision Research (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes