Dry Eye SyndromesDESBNCT00739713
Effects of Sea Buckthorn Oil on Dry Eye
A study testing Sea buckthorn (Hippophaë rhamnoides) oil in people with Dry Eye Syndromes, run by University of Turku at 1 site in Finland.
Trial summary
The objective is to study the effect of sea buckthorn oil on dry eye. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Sea buckthorn (Hippophaë rhamnoides) oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dry eye symptoms
Who cannot join
- Severe illness
- Anticholinergic drugs
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to study the effect of sea buckthorn oil on dry eye.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Sea buckthorn (Hippophaë rhamnoides) oil, Placebo comparison
- Keywords
- dry eye, sea buckthorn, Hippophaë
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea buckthorn (Hippophaë rhamnoides) oilDietary supplement
Dosage 2 g/d, frequency twice/d, duration 3 months
Placebo comparisonDietary supplement
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months
| Study group | Role | What they receive |
|---|---|---|
| SB | Experimental | Sea buckthorn oil group Receives: Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil |
| PL | Placebo comparator | Placebo group Receives: Dietary Supplement: Placebo comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity: symptom questionnaires and clinical dry eye tests
Measured: 3 months intervention + 1 month after the intervention
Secondary outcomes (1)
Tear film lipid profile, tear cytokines, inflammation mediators in blood
Measured: 3 months intervention + 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Heikki P Kallio, Professor, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739713
- Sponsor's protocol ID
- DESB
- Acronym
- DESB
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15539258Larmo 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.
PubMed 20554904
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sea Buckthorn Oil on Dry Eye
- ClinicalTrials.gov ID
- NCT00739713
- Acronym / sponsor ID
- DESB / DESB
- Conditions
- Dry Eye Syndromes
- Keywords
- dry eye, sea buckthorn, Hippophaë
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- 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
- Study start
- Sep 2008 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB | Experimental | Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oilSea buckthorn oil group |
| PL | Placebo comparator | Dietary Supplement: Placebo comparisonPlacebo group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dry eye symptoms
Key exclusion criteria (3 listed)
- Severe illness
- Anticholinergic drugs
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sea buckthorn (Hippophaë rhamnoides) oilDosage 2 g/d, frequency twice/d, duration 3 months | Dietary supplement | SB |
| Placebo comparisonPlacebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months | Dietary supplement | PL |
Primary outcome
Symptom severity: symptom questionnaires and clinical dry eye tests
Time frame: 3 months intervention + 1 month after the intervention
1 secondary outcome
Tear film lipid profile, tear cytokines, inflammation mediators in blood
Time frame: 3 months intervention + 1 month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 15539258Yang 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 publication: PubMed 20554904Larmo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki P Kallio, Professor study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sea buckthorn (Hippophaë rhamnoides) oil in people with Dry Eye Syndromes, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity: symptom questionnaires and clinical dry eye tests (time frame: 3 months intervention + 1 month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.