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 |
| Protocol serial number | N/A |
| Sponsor | Advanced Vision Research (USA) |
| Funder | Advanced Vision Research (USA) |
- 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
Scientific
Tufts University School of Dental Medicine
One Kneeland Street, Room 508
Boston
02111
United States of America
| Phone | +1 617 636 3931 |
|---|---|
| athena.papas@tufts.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, placebo-controlled, double-masked clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Use 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) studied | 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 |
| Primary outcome measure(s) |
Increased oral and ocular comfort at 3 months |
| Key secondary outcome measure(s) |
Increased salivary flow and improvement in gingival index (GI) at 3 months |
| Completion date | 04/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 65 |
| Key inclusion criteria | Subjects with Sjogren's syndrome as defined by the European Criteria and a positive blood test or lip biopsy |
| Key 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 |
| Date of first enrolment | 07/07/2005 |
| Date of final enrolment | 04/09/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Tufts University School of Dental Medicine
Boston
02111
United States of America
02111
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
