NCT00739713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

August 21, 2008

Last Update Submit

March 19, 2018

Conditions

Dry Eye Syndromes

Keywords

dry eyesea buckthornHippophaë

Outcome Measures

Primary Outcomes (1)

  • Symptom severity: symptom questionnaires and clinical dry eye tests

    3 months intervention + 1 month after the intervention

Secondary Outcomes (1)

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

    3 months intervention + 1 month after the intervention

Study Arms (2)

SB

EXPERIMENTAL

Sea buckthorn oil group

Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil

PL

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Placebo comparison

Interventions

Sea buckthorn (Hippophaë rhamnoides) oilDIETARY_SUPPLEMENT

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

SB
Placebo comparisonDIETARY_SUPPLEMENT

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

PL

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry eye symptoms

You may not qualify if:

  • Severe illness
  • Anticholinergic drugs
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20014, Finland

Location

Related Publications (2)

  • 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.

    PMID: 15539258BACKGROUND

  • 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.

    PMID: 20554904RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Oils

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

  • Heikki P Kallio, Professor

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2008

First Posted

August 22, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 20, 2018

Record last verified: 2017-03

Locations

FI(1)