ISRCTN10758297.
| Trial name or title |
Public title: the effect of a unique omega‐3 supplement on dry mouth and dry eye in Sjogren's patients Scientific title: the effect of a unique omega‐3 supplement on dry mouth and dry eye in Sjogren's patients |
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 65 participants (planned) Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
| Participants |
Participant characteristics Country: United States of America Age (mean ± SD, range): not reported Gender: not reported Inclusion criteria: subjects with Sjogren's syndrome as defined by the European Criteria and a positive blood test or lip biopsy Exclusion criteria: had less than 10 teeth; received periodontal therapy in the past 12 months or antibiotic therapy in the past 1 month; required pre‐medication with antibiotics had advanced periodontitis, an infectious or wasting disease; already supplementing with omega‐3s; participating in another clinical trial Equivalence of baseline characteristics? (Y/N): not reported |
| Interventions |
Intervention #1: 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, once a day Intervention #2 (control): placebo Length of follow‐up: 3 months Notes: none |
| Outcomes |
Primary outcome(s): increased oral and ocular comfort Secondary outcome(s): increased salivary flow and improvement in gingival index Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
| Starting date | July 2005 |
| Contact information | Dr Athena Papas Tufts University School of Dental Medicine One Kneeland Street Room 508, Boston, United States of America 02111 |
| Notes |
Date of last participant enrollment: September 4, 2007 Date clinical trial registry last updated: April 11, 2008 Recruitment status: no longer recruited Other notes: study sponsored by Advanced Vision Research |