Dietary Treatment for Chronic Urticaria (DTCU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hong Kong Sanatorium & Hospital
Sponsor:
Information provided by (Responsible Party):
Hong Kong Sanatorium & Hospital
ClinicalTrials.gov Identifier:
NCT02047136
First received: January 24, 2014
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

Histamine is a biologically active component that can be found in many foods and beverages. Intake of excessive histamine from foods or beverages, can trigger symptoms including urticaria. A low histamine diet has been recommended as one of the possible treatments for patients with chronic urticaria. There are very few studies to confirm the effectiveness of such diets and, to the investigators' knowledge, none from Asia where high histamine containing meals are often eaten (personal observations). The objective of the present study is to investigate the therapeutic effect of low histamine diet in relieving symptoms in patients with chronic urticaria with or without angioedema, and / or pruritus (U/A/P). The investigators hypothesize that following a low histamine diet for 4 weeks, the symptoms of patients with chronic U/A/P should improve.


Condition Intervention
Diet Modification
Chronic Urticaria
Other: Treatment group (on low histamine diet)
Other: Well-balanced diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Low Histamine Diet Reduce Symptoms of Patients With Idiopathic Urticaria?

Resource links provided by NLM:


Further study details as provided by Hong Kong Sanatorium & Hospital:

Primary Outcome Measures:
  • The change in Mean Total Symptoms Score (MTSS) from baseline between groups [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    When a subject comes for the first consultation (randomization week), he/she will be given a 4-point scale questionnaire (see Appendix II) to evaluate his/her own symptoms (pruritus severity and number of wheals). This will be completed once every evening for a week prior to the 4-week treatment period. The pruritus severity score and the number of wheals during this run in week will be averaged and used as the mean baseline score. The summation of mean pruritus score (MPS) and the mean number of wheals (MNW) will be the mean total symptoms score (MTSS) for the baseline period. Then comparison between the change in Mean Total Symptoms Score (MTSS) from baseline between treatment group and control group.


Secondary Outcome Measures:
  • the change in mean pruritus score (MPS) between treatment group and control group [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    When a subject comes for the first consultation (randomization week), he/she will be given a 4-point scale questionnaire (see Appendix II) to evaluate his/her own symptoms (pruritus severity and number of wheals). This will be completed once every evening for a week prior to the 4-week treatment period. The pruritus severity score and the number of wheals during this run in week will be averaged and used as the mean baseline score. The summation of mean pruritus score (MPS) and the mean number of wheals (MNW) will be the mean total symptoms score (MTSS) for the baseline period.

  • the change in mean number of wheals (MNW) between groups [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    When a subject comes for the first consultation (randomization week), he/she will be given a 4-point scale questionnaire to evaluate his/her own symptoms (pruritus severity and number of wheals). This will be completed once every evening for a week prior to the 4-week treatment period. The pruritus severity score and the number of wheals during this run in week will be averaged and used as the mean baseline score. The summation of mean pruritus score (MPS) and the mean number of wheals (MNW) will be the mean total symptoms score (MTSS) for the baseline period.

  • the change in global symptoms severity (GSS) by medical investigator between groups [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    Medical investigator will also evaluate the subject's global symptoms severity (GSS) at the first consultation (randomization week) and second consultation (at the end of week 4).

  • the comparison of area under the curve (AUC for the trend) for MTSS, MPS, MNW, GSS and DCS between the groups during the 4-week period [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

    When a subject comes for the first consultation (randomization week), he/she will be given a 4-point scale questionnaire to evaluate his/her own symptoms (pruritus severity and number of wheals). This will be completed once every evening for a week prior to the 4-week treatment period. The pruritus severity score and the number of wheals during this run in week will be averaged and used as the mean baseline score. The summation of mean pruritus score (MPS) and the mean number of wheals (MNW) will be the mean total symptoms score (MTSS) for the baseline period. Medical investigator will also evaluate the subject's global symptoms severity (GSS) at the first consultation (randomization week) and second consultation (at the end of week 4).

    MPS and GSS is scored as 0 = none; 1 = mild (present but not disturbing); 2 = moderate (disturbing but not hampering day time activities and/or sleep); and 3 = severe/intense (disturbing and hampering day time activities and/or sleep).



Estimated Enrollment: 78
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group (on low histamine diet)
78 subjects who come to Allergy Centre for treatment of idiopathic urticaria, with or without angioedema and pruritus (U/A/P), will be randomized into two parallel groups; treatment group (TG) will be asked to follow a histamine-restricted diet for 4 weeks and the control group (CG) will be asked to follow a well-balanced diet instructed by a dietitian for 4 weeks. A well-balanced diet for the CG subject is tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.
Other: Treatment group (on low histamine diet)
78 subjects who come to Allergy Centre for treatment of idiopathic urticaria, with or without angioedema and pruritus (U/A/P), will be randomized into two parallel groups; treatment group (TG) will be asked to follow a histamine-restricted diet for 4 weeks and the control group (CG) will be asked to follow a well-balanced diet instructed by a dietitian for 4 weeks. A well-balanced diet for the CG subject is tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.
Active Comparator: Well-balanced diet
Diet tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.
Other: Well-balanced diet
Diet tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Urticaria +/- angioedema present for a minimum of 6 weeks;
  • Agree to be on anti-histamine prn;
  • Age older than 8 years old, with no upper age limit;
  • Causes such as parasite infestation, microbial and viral infections, autoimmune disease, or other pathology that could account for the U/A/P should be excluded;
  • Skin prick test and/or radioallergosorbent (RAST) test are negative for all food allergens tested, or patient had achieved no symptomatic improvement after strict avoidance of all skin test-positive foods;

Exclusion Criteria:

  • Pregnant or breast feeding women;
  • Patients who is taking central nervous system (CNS) acting agents (including tranquilizers, antidepressants, sedatives, hypnotics or antiepileptics) at any time;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02047136

Contacts
Contact: Wai Yan Vivian Lau, Master 852-2835-7110 vivian.wy.lau@hksh.com
Contact: King Chi June Chan, Master 852-2835-8462 junechan@hksh.com

Locations
China
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, China
Contact: Wai Yan Vivian Lau, Master    852-2835-7110    vivian.wy.lau@hksh.com   
Contact: King Chi June Chan, Master    852-2835-8462    junechan@hksh.com   
Principal Investigator: Wai Yan Vivian Lau, Master         
Sub-Investigator: Tak Hong Lee, Professor         
Sub-Investigator: King Chi June Chan, Master         
Sponsors and Collaborators
Hong Kong Sanatorium & Hospital
Investigators
Principal Investigator: Wai Yan Vivian Lau, Master Hong Kong Sanatorium & Hospital
  More Information

Publications:
Responsible Party: Hong Kong Sanatorium & Hospital
ClinicalTrials.gov Identifier: NCT02047136     History of Changes
Other Study ID Numbers: ALC-001
Study First Received: January 24, 2014
Last Updated: February 13, 2014
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Urticaria
Food Habits
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Habits
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014