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Clinical Trials/NCT05810233
NCT05810233RecruitingNot Applicable

The Effect of Vitamin C on the Skin Prick Test Wheal Reaction

National University of Malaysia1 site in 1 country90 target enrollmentStarted: July 15, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Skin prick test wheal area of vitamin C group compared to placebo

Study Overview

Brief Summary

This study will assess the effect of taking vitamin C on allergy skin test.

Detailed Description

Allergic rhinitis (AR) is an Immunoglobulin E (IgE) mediated inflammation of the nasal cavity. House dust mite is the most common causative allergen. The skin prick test is the preferred method to confirm allergy. This test is interpreted by measuring the skin wheal reaction in response to allergen application and histamine. Prior studies have shown that Vitamin C may have antihistamine effect that may reduce the wheal reaction in skin prick test thus cause difficulties to interpret the results. Current guidelines do not recommend cessation of vitamin C prior to skin prick test. This will require further study in order to further understand the effect of vitamin C in commercially available dose on the skin prick test wheal reaction. In this randomized placebo controlled trial, consecutive participant visiting the ENT clinic with allergic rhinitis and prior positive skin prick test towards dust mite will be screened for inclusion and exclusion criteria. Participants will either receive vitamin C 1000mg daily for 7 days or placebo. The skin prick test will be performed after one week of intervention and the area of the wheal reaction area (mm2) and longest diameter (mm) recorded. This will be compared between the two groups. The expected outcome is that participants with oral supplementation of vitamin C will have reduced SPT wheal reaction compared to placebo group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Tablets will be despensed by a research assistant

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participants above 18-years old
  • •Participants with history at least 2 symptoms of rhinitis triggered by dust
  • •Positive SPT to Dermatophagoides pteronyssinus with wheal reaction of at least 5 mm done within the past 1 year.

Exclusion Criteria

  • •Prior skin prick test result form do not include a tracing of the wheal reaction.
  • •Prior skin prick test was not performed in HCTM.
  • •Participants who are actively smoking or who have smoked cigarette or vaped in the past 6 months
  • •Participants with skin conditions affecting the volar aspects of the arm.
  • •Participants on beta-blockers
  • •Participants contraindicated for skin prick test (pregnancy, history of anaphylaxis, poorly controlled asthma)
  • •Participants on long term supplements (multivitamin, traditional supplement)
  • •Participants contraindicated for vitamin c (vitamin c allergy, kidney dysfunction, history of kidney or bladder stones, hyperuricemia, thalassemia, G6PD deficiency, sickle cell disease, hamatochromatosis)
  • •Participants at risk of vitamin C deficiency (hyperthyroidism, elderly, beastfeeding, diarrhoea, restricted diet secondary to inflammatory bowel disease, anorexia or cancer)

Arms & Interventions

Vitamin C

Experimental

Commercially available Tablet Vitamin C 1000mg per day for 7 days

Intervention: Ascorbic acid 1000mg (Dietary Supplement)

Placebo

Placebo Comparator

Glucose chewable table 1x per day for seven days

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Skin prick test wheal area of vitamin C group compared to placebo

Time Frame: Day 8

Skin wheal reaction is measured using computer software. Day 8 wheal area of vitamin C group compared to placebo.

Secondary Outcomes

  • Skin prick test wheal reaction at day 8 of intevention compraed to prior skin prick test done as standard of care(Day 8)

Investigators

Sponsor
National University of Malaysia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ANEEZA KHAIRIYAH WAN HAMIZAN

Associate Professor, Dr

National University of Malaysia

Study Sites (1)

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