The effect of a unique omega-3 supplement on dry mouth and dry eye in Sjogren's patients

ISRCTN ISRCTN10758297
DOI https://doi.org/10.1186/ISRCTN10758297
Secondary identifying numbers N/A
Submission date
07/02/2007
Registration date
27/03/2007
Last edited
04/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Athena Papas
Scientific

Tufts University School of Dental Medicine
One Kneeland Street, Room 508
Boston
02111
United States of America

Phone +1 617 636 3931
Email athena.papas@tufts.edu

Study information

Study designProspective, randomised, placebo-controlled, double-masked clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesUse of omega-3 supplements can increase oral and ocular comfort and increase salivary flow in Sjogren's patients.
Ethics approval(s)Ethics approval received from the Institutional Review Board - Tufts University Health Sciences/Tufts - New England Medical Center on the 16th May 2005 (ref: 7370)
Health condition(s) or problem(s) studiedSjogren's syndrome
InterventionUse 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 typeOther
Primary outcome measureIncreased oral and ocular comfort at 3 months
Secondary outcome measuresIncreased salivary flow and improvement in gingival index (GI) at 3 months
Overall study start date07/07/2005
Completion date04/09/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants65
Key inclusion criteriaSubjects with Sjogren's syndrome as defined by the European Criteria and a positive blood test or lip biopsy
Key exclusion criteria1. 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
Date of first enrolment07/07/2005
Date of final enrolment04/09/2007

Locations

Countries of recruitment

  • United States of America

Study participating centre

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

Sponsor information

Advanced Vision Research (USA)
Industry

660 Main St., 1st Floor
Woburn
Massachusetts
01801
United States of America

Phone +1 800 231 3316
Email jgilbard@theratears.com

Funders

Funder type

Industry

Advanced Vision Research (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan