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Effects of Sea Buckthorn Oil on Dry Eye (DESB)

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Sea buckthorn (Hippophaë rhamnoides) oil
Placebo comparison
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye, sea buckthorn, Hippophaë

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Dry eye symptoms

Exclusion Criteria:

  • Severe illness
  • Anticholinergic drugs
  • Smoking

Sites / Locations

  • University of Turku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SB

PL

Arm Description

Sea buckthorn oil group

Placebo group

Outcomes

Primary Outcome Measures

Symptom severity: symptom questionnaires and clinical dry eye tests

Secondary Outcome Measures

Tear film lipid profile, tear cytokines, inflammation mediators in blood

Full Information

First Posted
August 21, 2008
Last Updated
March 19, 2018
Sponsor
University of Turku
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)
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1. Study Identification

Unique Protocol Identification Number
NCT00739713
Brief Title
Effects of Sea Buckthorn Oil on Dry Eye
Acronym
DESB
Official Title
Effects of Sea Buckthorn Oil on Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (Actual)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turku
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)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
dry eye, sea buckthorn, Hippophaë

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB
Arm Type
Experimental
Arm Description
Sea buckthorn oil group
Arm Title
PL
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
Sea buckthorn (Hippophaë rhamnoides) oil
Intervention Description
Dosage 2 g/d, frequency twice/d, duration 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo comparison
Intervention Description
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months
Primary Outcome Measure Information:
Title
Symptom severity: symptom questionnaires and clinical dry eye tests
Time Frame
3 months intervention + 1 month after the intervention
Secondary Outcome Measure Information:
Title
Tear film lipid profile, tear cytokines, inflammation mediators in blood
Time Frame
3 months intervention + 1 month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dry eye symptoms Exclusion Criteria: Severe illness Anticholinergic drugs Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki P Kallio, Professor
Organizational Affiliation
University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20014
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15539258
Citation
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.
Results Reference
background
PubMed Identifier
20554904
Citation
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.
Results Reference
result

Learn more about this trial

Effects of Sea Buckthorn Oil on Dry Eye

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