Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by October 6 University.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Amr Moustafa Elkhouli, October 6 University
First received: April 5, 2013
Last updated: April 10, 2013
Last verified: April 2013
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
Recurrent Mouth Ulcers
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
Primary Outcome Measures:
- quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
Measurement of oral health related quality of life (OHR-QoL),this parameter was carried out at baseline, and at 6 months of the study using the Arabic version of oral health impact profile-14 (OHIP-14) questionnaire.
Secondary Outcome Measures:
- Pain associated with the ulcers [ Time Frame: Six months ] [ Designated as safety issue: No ]
The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS).
- Duration of ulcers episode [ Time Frame: Six months ] [ Designated as safety issue: No ]
The time needed for the ulcer to heal
- The monthly number of ulcer outbreaks [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
The number of ulcers appears monthly in the mouth
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Placebo Comparator: isopropylmyristate oil
placebo Soft gelatinous capsules filled with isopropylmyristate oil
soft gelatinous capsules filled with isopropylmyristate oil
Other Name: isopropylmyristate oil
Active Comparator: experimental
omega-3 1 gram three times daily for 6 months
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
Other Name: fish oil
In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.
|Ages Eligible for Study:
||13 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female patients older than 13 years of age
- Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
- History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
- Normal sense of pain, without anesthesia or paresthesia.
- Willingness to participate and sign the informed consent.
1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.
2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.
4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.
5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01831453
|October 6 university
|Cairo, Governarate of 6 of October, Egypt, 11348 |
October 6 University
||Amr M Elkhouli, ass prof
||October 6 University
Hjorth E, Zhu M, Toro VC, Vedin I, Palmblad J, Cederholm T, Freund-Levi Y, Faxen-Irving G, Wahlund LO, Basun H, Eriksdotter M, Schultzberg M. Omega-3 fatty acids enhance phagocytosis of Alzheimer's disease-related amyloid-β42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131.
||Amr Moustafa Elkhouli, Associate professor, October 6 University
History of Changes
|Other Study ID Numbers:
||Dr. Amr Elkhouli 1962
|Study First Received:
||April 5, 2013
||April 10, 2013
||Egypt: Institutional Review Board
Keywords provided by October 6 University:
recurrent aphthous stomatitis
quality of life
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015