NCT05810233

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

March 30, 2023

Last Update Submit

August 28, 2023

Conditions

Keywords

ascorbic acidskin prick testvitamin Cantihistamine

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Day 8

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Dietary Supplement: Ascorbic acid 1000mg

Placebo

PLACEBO COMPARATOR

Glucose chewable table 1x per day for seven days

Other: Placebo

Interventions

Ascorbic acid 1000mgDIETARY_SUPPLEMENT

Health supplement

Also known as: VItamin C
Vitamin C
PlaceboOTHER

Glucose chewable tablet without any ascorbic acid

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Canselor Tuanku Mukhriz

Cheras, WP Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 11449200BACKGROUND
  • 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.

    PMID: 7076989BACKGROUND

MeSH Terms

Conditions

Rhinitis, AllergicHypersensitivity

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Aneeza K W Hamizan

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneeza K W Hamizan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Tablets will be despensed by a research assistant
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Participant assigned to only one intervention per arm either vitamin C or placebo tablets
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dr

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

July 15, 2023

Primary Completion

September 30, 2023

Study Completion

January 30, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations