Dietary Treatment for Chronic Urticaria

NCT02047136 | Terminated DMC

• 1 other identifier: ALC-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Modification; Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

• The change in Mean Total Symptoms Score (MTSS) from baseline between groups

  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.

  4 weeks

Secondary Outcomes (4)

• the change in mean pruritus score (MPS) between treatment group and control group

  4 week

• the change in mean number of wheals (MNW) between groups

  4 week

• the change in global symptoms severity (GSS) by medical investigator between groups

  5 weeks

• 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

  4 week

Study Arms (2)

Treatment group (on low histamine diet)

EXPERIMENTAL

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)

Well-balanced diet

ACTIVE COMPARATOR

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

Interventions

Treatment group (on low histamine diet) OTHER

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.

Treatment group (on low histamine diet)

Well-balanced diet OTHER

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.

Well-balanced diet

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead

Study Sites (1)

Hong Kong Sanatorium & Hospital

Hong Kong, China

Location

Related Publications (2)

• Maintz L, Novak N. Histamine and histamine intolerance. Am J Clin Nutr. 2007 May;85(5):1185-96. doi: 10.1093/ajcn/85.5.1185.

  PMID: 17490952 RESULT

• Janice M. Vickerstaff Joneja, Cabrini Carmona-Silva. Outcome of a Histamine-restricted Diet Based on Chart Audit. Journal of Nutritional and Environmental Medicine 11(4): 249-262, 2001.

  RESULT

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wai Yan Vivian Lau, Master

  Hong Kong Sanatorium & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

CN (1)