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NCT00739713 Clinical Trial

Effects of Sea Buckthorn Oil on Dry Eye

Dry Eye Syndromes Clinical Trial

— DESB  

Official title:
Effects of Sea Buckthorn Oil on Dry Eye

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00739713
Other study ID # DESB
Secondary ID
Status Completed
Phase N/A
First received August 21, 2008
Last updated March 19, 2018
Start date September 2008
Est. completion date March 2009

Study information
Verified date March 2017
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to study the effect of sea buckthorn oil on dry eye.

Description:

The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Dry eye symptoms

Exclusion Criteria:

- Severe illness

- Anticholinergic drugs

- Smoking

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Sea buckthorn (Hippophaë rhamnoides) oil
Dosage 2 g/d, frequency twice/d, duration 3 months
• Placebo comparison
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Locations
Country Name City State
Finland University of Turku Turku

Sponsors (8)
Lead Sponsor Collaborator
University of Turku Aromtech Ltd., Finnsusp Ltd., Shiny Horse Ltd, The Finnish Funding Agency for Technology and Innovation (TEKES), Turku Municipal Health Department/evo-funding, Turku University Hospital, Valioravinto Ltd

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Larmo PS, Järvinen RL, Setälä NL, Yang B, Viitanen MH, Engblom JR, Tahvonen RL, Kallio HP. Oral sea buckthorn oil attenuates tear film osmolarity and symptoms in individuals with dry eye. J Nutr. 2010 Aug;140(8):1462-8. doi: 10.3945/jn.109.118901. Epub 20 — View Citation

Yang B, Kalimo KO, Mattila LM, Kallio SE, Katajisto JK, Peltola OJ, Kallio HP. Effects of dietary supplementation with sea buckthorn (Hippophaë rhamnoides) seed and pulp oils on atopic dermatitis. J Nutr Biochem. 1999 Nov;10(11):622-30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom severity: symptom questionnaires and clinical dry eye tests 3 months intervention + 1 month after the intervention
Secondary Tear film lipid profile, tear cytokines, inflammation mediators in blood 3 months intervention + 1 month after the intervention
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