Effects of Sea Buckthorn Oil on Dry Eye

NCT ID: NCT00739713

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SB

Sea buckthorn oil group

Group Type EXPERIMENTAL

Sea buckthorn (Hippophaƫ rhamnoides) oil

Intervention Type DIETARY_SUPPLEMENT

Dosage 2 g/d, frequency twice/d, duration 3 months

PL

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo comparison

Intervention Type DIETARY_SUPPLEMENT

Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Interventions

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Sea buckthorn (Hippophaƫ rhamnoides) oil

Dosage 2 g/d, frequency twice/d, duration 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo comparison

Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Dry eye symptoms

Exclusion Criteria

* Severe illness
* Anticholinergic drugs
* Smoking
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turku Municipal Health Department/evo-funding

UNKNOWN

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Finnsusp Ltd.

INDUSTRY

Sponsor Role collaborator

Aromtech Ltd.

INDUSTRY

Sponsor Role collaborator

Shiny Horse Ltd

UNKNOWN

Sponsor Role collaborator

Valioravinto Ltd

UNKNOWN

Sponsor Role collaborator

The Finnish Funding Agency for Technology and Innovation (TEKES)

OTHER_GOV

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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University of Turku

Principal Investigators

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Heikki P Kallio, Professor

Role: STUDY_DIRECTOR

University of Turku

Locations

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University of Turku

Turku, , Finland

Site Status

Countries

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Finland

References

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Yang B, Kalimo KO, Mattila LM, Kallio SE, Katajisto JK, Peltola OJ, Kallio HP. Effects of dietary supplementation with sea buckthorn (Hippophae rhamnoides) seed and pulp oils on atopic dermatitis. J Nutr Biochem. 1999 Nov;10(11):622-30. doi: 10.1016/s0955-2863(99)00049-2.

Reference Type BACKGROUND
PMID: 15539258 (View on PubMed)

Larmo PS, Jarvinen RL, Setala 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.

Reference Type RESULT
PMID: 20554904 (View on PubMed)

Other Identifiers

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DESB

Identifier Type: -

Identifier Source: org_study_id

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