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临床试验/NCT05810233
NCT05810233招募中不适用

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

National University of Malaysia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Skin prick test wheal area of vitamin C group compared to placebo

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Tablets will be despensed by a research assistant

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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)

研究组 & 干预措施

Vitamin C

Experimental

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

干预措施: Ascorbic acid 1000mg (Dietary Supplement)

Placebo

Placebo Comparator

Glucose chewable table 1x per day for seven days

干预措施: Placebo (Other)

结局指标

主要结局

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

时间窗: Day 8

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

次要结局

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

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANEEZA KHAIRIYAH WAN HAMIZAN

Associate Professor, Dr

National University of Malaysia

研究点 (1)

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