Effects of Sea Buckthorn Oil on Dry Eye (DESB)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2009 by University of Turku.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborators:

Turku Municipal Health Department/evo-funding

Turku University Hospital

Finnsusp Ltd.

Aromtech Ltd.

Shiny Horse Ltd

Valioravinto Ltd

The Finnish Funding Agency for Technology and Innovation (TEKES)

Information provided by:

University of Turku

ClinicalTrials.gov Identifier:

NCT00739713

First received: August 21, 2008

Last updated: June 24, 2010

Last verified: February 2009

History of Changes

Purpose

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

Condition	Intervention
Dry Eye Syndromes	Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil Dietary Supplement: Placebo comparison


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Sea Buckthorn Oil on Dry Eye

Resource links provided by NLM:

Drug Information available for: Buckthorn extract

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

Symptom severity: symptom questionnaires and clinical dry eye tests [ Time Frame: 3 months intervention + 1 month after the intervention ]

Secondary Outcome Measures:

Tear film lipid profile, tear cytokines, inflammation mediators in blood [ Time Frame: 3 months intervention + 1 month after the intervention ]


Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SB Sea buckthorn oil group	Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil Dosage 2 g/d, frequency twice/d, duration 3 months
Placebo Comparator: PL Placebo group	Dietary Supplement: Placebo comparison Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Detailed 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.

Eligibility


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Dry eye symptoms

Exclusion Criteria:

Severe illness
Anticholinergic drugs
Smoking

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739713

Locations


Finland
University of Turku
Turku, Finland, 20014

Sponsors and Collaborators

University of Turku

Turku Municipal Health Department/evo-funding

Turku University Hospital

Finnsusp Ltd.

Aromtech Ltd.

Shiny Horse Ltd

Valioravinto Ltd

The Finnish Funding Agency for Technology and Innovation (TEKES)

Investigators


Study Director:	Heikki P Kallio, Professor	University of Turku

More Information

Publications:

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 2010 Jun 16.

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.


Responsible Party:	Matti Viitanen/ Professor, University of Turku
ClinicalTrials.gov Identifier:	NCT00739713 History of Changes
Other Study ID Numbers:	DESB
Study First Received:	August 21, 2008
Last Updated:	June 24, 2010

Keywords provided by University of Turku:


dry eye sea buckthorn Hippophaë

Additional relevant MeSH terms:


Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases	Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 21, 2017

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