Rhinitis, AllergicNCT05810233
Effect of Vitamin C on Allergy Skin Test
A study testing Ascorbic acid 1000mg in people with Rhinitis, Allergic and Allergy, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study will assess the effect of taking vitamin C on allergy skin test. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Rhinitis, Allergic, Allergy
- What is being tested?
- Ascorbic acid 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Jul 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Mukhriz
Cheras, WP Kuala Lumpur, 56000
Aneeza W Hamizan, PhD, 0391455555 ext. 6057, draneeza@ukm.edu.my
About this study
Official title: The Effect of Vitamin C on the Skin Prick Test Wheal Reaction
This study will assess the effect of taking vitamin C on allergy skin test.
Read the 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.
- Conditions
- Rhinitis, Allergic, Allergy
- Being tested
- Ascorbic acid 1000mg, Placebo
- Keywords
- ascorbic acid, skin prick test, vitamin C, antihistamine
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acid 1000mgDietary supplement
Also called VItamin C
Health supplement
PlaceboOther
Glucose chewable tablet without any ascorbic acid
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Commercially available Tablet Vitamin C 1000mg per day for 7 days Receives: Dietary Supplement: Ascorbic acid 1000mg |
| Placebo | Placebo comparator | Glucose chewable table 1x per day for seven days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 8
Secondary outcomes (1)
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.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start15 Jul 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant assigned to only one intervention per arm either vitamin C or placebo tablets
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANEEZA KHAIRIYAH WAN HAMIZAN, National University of Malaysia
- Investigators
- Aneeza K W Hamizan, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810233
- Sponsor's protocol ID
- JEP-2023
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared if journal is required
Publications
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.
PubMed 11449200Fortner 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.
PubMed 7076989
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C on the Skin Prick Test Wheal Reaction
- ClinicalTrials.gov ID
- NCT05810233
- Acronym / sponsor ID
- JEP-2023
- Conditions
- Rhinitis, Allergic, Allergy
- Keywords
- ascorbic acid, skin prick test, vitamin C, antihistamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participant assigned to only one intervention per arm either vitamin C or placebo tablets
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Dietary Supplement: Ascorbic acid 1000mgCommercially available Tablet Vitamin C 1000mg per day for 7 days |
| Placebo | Placebo comparator | Other: PlaceboGlucose chewable table 1x per day for seven days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acid 1000mgAlso: VItamin CHealth supplement | Dietary supplement | Vitamin C |
| PlaceboGlucose chewable tablet without any ascorbic acid | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Skin prick test wheal reaction at day 8 of intevention compraed to prior skin prick test done as standard of care
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 11449200Skoner 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.
- Background: PubMed 7076989Fortner 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.
- Individual participant dataSharing planned: Undecided. Data will be shared if journal is required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneeza K W Hamizan principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid 1000mg in people with Rhinitis, Allergic and Allergy, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneeza K W Hamizan, MD (0391455555 ext. 6046, draneeza@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin prick test wheal area of vitamin C group compared to placebo (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.