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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201111000336400 Date registered: 2011/11/05
TRIAL DESCRIPTION
Public title The effect zinc supplementation on asthma in Egyptian children Protocol for a subgroup analysis [retrospectively registered]
Official scientific title The effect zinc supplementation on asthma in Egyptian children Protocol for a subgroup analysis
Brief summary describing the background
and objectives of the trial
Previously, Al-Biltagi et al. found that 15 mg/day zinc decreased the severity of asthma and increased FEV1 in 60 Egyptian children (5).In the planned study we aimed to do initiating the zinc subgroup comparisons to investigate the factors affecting zinc effects on asthmatic children.
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 2011-11-30
Actual trial start date 2011-11-30
Anticipated date of last follow up 2012-04-02
Actual date of last follow up
Anticipated target sample size (number of participants) 75   
Actual target sample size (number of participants) 60   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Vit C at intake - Group a 200mg ascorbic acid; Placebo; 15mg zinc +200mg ascorbic acid+1000mg triglycercide; 1000mg triglyc; 15mg Zinc/day 6 weeks of each with two week washout period between each 6wks Vit C, 6 wks placebo, 6 wks combined, 6 wks Omega 3, 6 weeks zinc 15
Experimental group Zinc at intake - Group b 15 mg Z/day; 200mg ascorbic acide; Placebo; 15mg zinc +200mg ascorbic acid+1000mg triglycercide; 1000mg triglyc 6 weeks of each The children receive 6 weeks of Zinc capsule; pulmonary functions before and after the 6 weeks of zinc supplement 15
Experimental group Omega 3 at intake - Group c daily for each 1000mg triglyceride; 15mg zinc; 200mg ascorbic acid; placebo; 15mg zinc+200mg ascorbic acid+1000mg triglyceride 6 weeks of each with two week washout period between each 6wks Omega 3; 6 wks Zinc; 6 wks Vit C; 6 wks placebo; 6 wks combined 15
Experimental group Combined at intake - group d Daily for each - 15mg zinc+200mg ascorbic acid+1000mg triglyceride; 1000mg triglyceride; 15mg zinc; 200mg ascorbic acid; placebo 6 weeks of each with two week washout period between each 6 wks combined; 6wks Omega 3; 6 wks Zinc; 6 wks Vit C; 6 wks placebo; 15
Experimental group Placebo at intake - group e Daily for each - placebo; 15mg zinc+200mg ascorbic acid+1000mg triglyceride; 1000mg triglyceride; 15mg zinc; 200mg ascorbic acid 6 weeks of each with two week washout period between each 6 wks placebo; 6 wks combined; 6wks Omega 3; 6 wks Zinc; 6 wks Vit C; 15

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Age 7 and 10 years Having moderate persistent bronchial asthma Any chronic diseases other than asthma and rhinitis. Intake of antileukotrienes during the study. Children taking n-3 polyunsaturated fatty acid (PUFA) or antioxidants supplements above the levels recommended for adequate intake, or regularly consumed more than one fish meal per week. Manifestations of vitamin C or Zn deficiency. 7 Years 10 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes Ithical Commeettee, Peditric Department, Tanta, Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Al Bahr street Tanta 0000 Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement of the lung functions The end of the 6 weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Asthma Clinic of Paediatric Department, Faculty of Medicine, Tanta University Al Bahr street, Medical complex Tanta 0000 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Al Bahr street Tanta 0000 Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Al Bahr street Tanta 0000 Egypt University

COLLABORATORS
Name Street address City Postal code Country
University of Helsinki, 0000 Helsinki, 0000 Finland

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Mohammed Al-Biltaagi mbelrem@hotmail.com +20102209797
Street address City Postal code Country Position / Affiliation
Al bahr street Tanta 0000 Egypt Ass. Professor
Role Name Email Phone Fax
Principal Investigator Prof Harri Hemilä harri.hemila@helsinki.fi + 358 9 19126629 + 358 9 19126629
Street address City Postal code Country Position / Affiliation
Tukholmankatu 8 B, 5th and 6th floors faculty of Medicine HELSINKI 00000 Finland Professro of Public health
Role Name Email Phone Fax
Scientific Enquiries Prof Mohammed Al-Biltaagi mbelrem@hotmail.com +20102209797 20402213543
Street address City Postal code Country Position / Affiliation
Al bahr street Tanta 0000 Egypt Ass. Prof of Pediatrics
Role Name Email Phone Fax
Public Enquiries Prof Mohammed Al-Biltaagi mbelrem@hotmail.com +20102209797 20402213543
Street address City Postal code Country Position / Affiliation
Al bahr street Tanta 0000 Egypt Ass. Prof of Pediatrics