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