NCT04308161

Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis

Detailed description

The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment. All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.

Conditions

• Oral Mucositis Due to Radiation

Interventions

Type	Name	Description
DRUG	vitamin D oral gel	vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
DRUG	Miconazole Topical Gel	topical anti fungal agent
DRUG	BBC oral spray	Topical anesthetics and anti-inflammatory agent
DRUG	Oracure gel	Topical analgesic gel
OTHER	Alkamisr sachets	Sodium bicarbonate mouthwash

Timeline

• Start date: 2019-11-02
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2020-03-13
• Last updated: 2020-03-13

Locations

1 site across 1 country: Egypt