NCT01697085

Brief Summary

Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

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

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

September 27, 2012

Last Update Submit

January 27, 2016

Conditions

Mucous Membranes

Keywords

sea buckthornmucous membranedrynessmetabolic syndromevaginal atrophy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in dryness related symptoms of genital mucous membranes

    Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention

    Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)

Secondary Outcomes (1)

  • Change from baseline in vaginal pH

    At baseline, at 3 months (end of intervention)

Other Outcomes (1)

  • Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation

    At baseline, at 3 months (end of intervention)

Study Arms (2)

Sea buckthorn oil

EXPERIMENTAL

3 g (6 capsules)/day for three months

Dietary Supplement: Sea buckthorn oil

Placebo oil

PLACEBO COMPARATOR

3 g (6 capsules)/day for three months

Dietary Supplement: Placebo oil

Interventions

Sea buckthorn oilDIETARY_SUPPLEMENT
Sea buckthorn oil
Placebo oilDIETARY_SUPPLEMENT
Placebo oil

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women experiencing vaginal dryness
  • years of age
  • at least 12 months from menstruation

You may not qualify if:

  • use of estrogen replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turun Gynekologikeskus

Turku, 20100, Finland

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Risto Erkkola, Professor

    Turun Gynekologikeskus, Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
R&D manager, Ph.D.

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 2, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

FI(1)