The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children

NCT ID: NCT02745899

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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the investigators hypothesis is that milk consumption, either in the acute phase and through prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation. the investigators aim to objectively prove this by examining respiratory symptoms and signs and objectively measuring parameters of airway inflammation and hyper responsiveness after consumption of cow milk or soy milk substitute.

Detailed Description

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In this prospective single blinded placebo controlled trial, acute milk consumption will be evaluated. 50 asthmatic and 50 healthy children aged 6-18 will drink 240 ml of cow milk or soy milk substitute. Respiratory symptoms by questionnaire and physical examination will be evaluated. Airway response and inflammation will be assessed by fraction of exhaled Nitric Oxide (FENO) and spirometry before and after the exposure.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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Soy milk substitute Healthy

Healthy children aged 6-18 will drink 240 ml of soy milk substitute.

Group Type ACTIVE_COMPARATOR

Soy milk

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 240 ml soy milk

Soy milk substitute Asthma

Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute.

Group Type ACTIVE_COMPARATOR

Soy milk

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 240 ml soy milk

Cow milk Healthy

Healthy children aged 6-18 will drink 240 ml of cow milk.

Group Type EXPERIMENTAL

Cow milk

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 240 ml cow milk

Cow milk Asthma

Asthmatic children aged 6-18 will drink 240 ml of cow milk.

Group Type EXPERIMENTAL

Cow milk

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 240 ml cow milk

Interventions

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Cow milk

Ingestion of 240 ml cow milk

Intervention Type DIETARY_SUPPLEMENT

Soy milk

Ingestion of 240 ml soy milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy children
* Asthmatic children

Exclusion Criteria

* Known allergy to cow milk
* Children had upper / lower respiratory disease in two weeks prior the study.
* Children who had been treated in systemic steroids in the month prior the study.
* Intolerant children to cow milk.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keren Armoni Domany, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Pulmonology, Critical Care and Sleep Medicine Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center

Central Contacts

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Keren Armoni Domany, Doctor

Role: CONTACT

+972-3-6974614

References

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Koren Y, Armoni Domany K, Gut G, Hadanny A, Benor S, Tavor O, Sivan Y. Respiratory effects of acute milk consumption among asthmatic and non-asthmatic children: a randomized controlled study. BMC Pediatr. 2020 Sep 12;20(1):433. doi: 10.1186/s12887-020-02319-y.

Reference Type DERIVED
PMID: 32919454 (View on PubMed)

Other Identifiers

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TASMC-16-KA-0070-16-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id

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