Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients

NCT01831453 | Unknown Phase 2

• 1 other identifier: Dr. Amr Elkhouli 1962
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

Conditions

Recurrent Mouth Ulcers

Keywords

omega-3; recurrent aphthous stomatitis; quality of life

Outcome Measures

Primary Outcomes (1)

• quality of life

  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.

  six months

Secondary Outcomes (3)

• Pain associated with the ulcers

  Six months

• Duration of ulcers episode

  Six months

• The monthly number of ulcer outbreaks

  Monthly for six months

Study Arms (2)

isopropylmyristate oil

PLACEBO COMPARATOR

placebo Soft gelatinous capsules filled with isopropylmyristate oil

Drug: placebo

experimental

ACTIVE COMPARATOR

omega-3 1 gram three times daily for 6 months

Drug: omega-3

Interventions

omega-3 DRUG

polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months

Also known as: fish oil

experimental

placebo DRUG

soft gelatinous capsules filled with isopropylmyristate oil

Also known as: isopropylmyristate oil

isopropylmyristate oil

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.
• Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.
• Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.
• 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.

Sponsors & Collaborators

• October 6 University: lead
• Tanta University: collaborator

Study Sites (1)

October 6 university

Cairo, Governarate of 6 of October, 11348, Egypt

Location

Related Publications (1)

• 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-beta42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131.

  PMID: 23481688 BACKGROUND

Related Links

• alzheimers

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Docosahexaenoic Acids; Fish Oils; isopropyl myristate

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Amr M Elkhouli, ass prof

  October 6 University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

EG (1)