search
Back to results

Effect of Vitamin C on Allergy Skin Test

Primary Purpose

Rhinitis, Allergic, Allergy

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Ascorbic acid 1000mg
Placebo
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rhinitis, Allergic focused on measuring ascorbic acid, skin prick test, vitamin C, antihistamine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Canselor Tuanku MukhrizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin C

Placebo

Arm Description

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

Glucose chewable table 1x per day for seven days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Skin prick test wheal reaction at day 8 of intevention compraed to prior skin prick test done as standard of care
Skin wheal reaction are is measured from prior skin test record (baseline) and at day 8 skin test repeated and measured. Area at day 7 - baseline.

Full Information

First Posted
March 30, 2023
Last Updated
August 28, 2023
Sponsor
National University of Malaysia
search

1. Study Identification

Unique Protocol Identification Number
NCT05810233
Brief Title
Effect of Vitamin C on Allergy Skin Test
Official Title
The Effect of Vitamin C on the Skin Prick Test Wheal Reaction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Allergy
Keywords
ascorbic acid, skin prick test, vitamin C, antihistamine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participant assigned to only one intervention per arm either vitamin C or placebo tablets
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Tablets will be despensed by a research assistant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Commercially available Tablet Vitamin C 1000mg per day for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Glucose chewable table 1x per day for seven days
Intervention Type
Dietary Supplement
Intervention Name(s)
Ascorbic acid 1000mg
Other Intervention Name(s)
VItamin C
Intervention Description
Health supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Glucose chewable tablet without any ascorbic acid
Primary Outcome Measure Information:
Title
Skin prick test wheal area of vitamin C group compared to placebo
Description
Skin wheal reaction is measured using computer software. Day 8 wheal area of vitamin C group compared to placebo.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Skin prick test wheal reaction at day 8 of intevention compraed to prior skin prick test done as standard of care
Description
Skin wheal reaction are is measured from prior skin test record (baseline) and at day 8 skin test repeated and measured. Area at day 7 - baseline.
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aneeza K W Hamizan, MD
Phone
0391455555
Ext
6046
Email
draneeza@ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneeza K W Hamizan
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Canselor Tuanku Mukhriz
City
Cheras
State/Province
WP Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneeza W Hamizan, PhD
Phone
0391455555
Ext
6057
Email
draneeza@ukm.edu.my

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared if journal is required
Citations:
PubMed Identifier
11449200
Citation
Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S2-8. doi: 10.1067/mai.2001.115569.
Results Reference
background
PubMed Identifier
7076989
Citation
Fortner BR Jr, Danziger RE, Rabinowitz PS, Nelson HS. The effect of ascorbic acid on cutaneous and nasal response to histamine and allergen. J Allergy Clin Immunol. 1982 Jun;69(6):484-8. doi: 10.1016/0091-6749(82)90171-3.
Results Reference
background

Learn more about this trial

Effect of Vitamin C on Allergy Skin Test

We'll reach out to this number within 24 hrs