UMIN-CTR Clinical Trial

Public title

Effects of beta-carotene on nasal and ocular symptoms in subjects with allergic rhinitis: a systematic review with meta-analysis

Acronym

Effects of beta-carotene on nasal and ocular symptoms in subjects with allergic rhinitis

Scientific Title

Effects of beta-carotene on nasal and ocular symptoms in subjects with allergic rhinitis: a systematic review with meta-analysis

Scientific Title:Acronym

Effects of beta-carotene on nasal and ocular symptoms in subjects with allergic rhinitis

Region

Japan

Condition

We will include healthy people who do not use or people who sometime use allergy medications. We will exclude minors (less than 18 years old), pregnant women, those planning a pregnancy, and lactating women.

Classification by specialty

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this study is to assess the effects of beta-carotene on nasal and ocular symptoms in subjects with allergic rhinitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

We will evaluate the effect of beta-carotene intake on the nasal markers of comfortability (Japanese allergic rhinitis standard quality of life questionnaire (JRQLQ) and the similar markers in foreign countries).

Key secondary outcomes

We will evaluate the effect of beta-carotene intake on the nasal-ocular and ocular markers of comfortability (JRQLQ and the similar markers in foreign countries).

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(Study design)
We will include randomized controlled parallel trials (RCT-P), randomized controlled crossover trials (RCT-C), quasi- randomized controlled parallel trials (qRCT-P), quasi- randomized controlled crossover trials (qRCT-C), non-randomized controlled parallel trials (nonRCT-P), non-randomized controlled crossover trials (nonRCT-C), and non-randomized controlled trials.
We will include scientific papers and reports which give us enough research details.

(PICO)
Participant:
We will include healthy people who do not use or people who sometime use allergy medications. We will exclude minors (less than 18 years old), pregnant women, those planning a pregnancy, and lactating women.

Intervention:
We define oral intake of beta-carotene as an intervention.

Comparison:
We define oral intake of test food not containing beta-carotene, as controls.
We also define maintaining daily life as a control.

Outcome measurement:
We will evaluate nasal markers of comfortability (Japanese allergic rhinitis standard quality of life questionnaire (JRQLQ) and the similar markers in foreign countries) as primary outcome.
We will evaluate nasal-ocular and ocular markers of comfortability (JRQLQ and the similar markers in foreign countries) as secondary outcomes.


(Language)
Eligibility is not restricted by language.

Key exclusion criteria

We will exclude proceedings and unpublished studies which don't give us enough research details.

Target sample size

100

Name of lead principal investigator

1st name	Takuro
Middle name
Last name	Inoue

Organization

KAGOME CO., LTD.

Division name

Innovation Division

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobara-shi, Tochigi

TEL

0287-36-2935

Email

g167_0@kagome.co.jp

Name of contact person

1st name	Takuro
Middle name
Last name	Inoue

Organization

KAGOME CO., LTD.

Division name

Innovation Division

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobara-shi, Tochigi

TEL

0287-36-2935

Homepage URL

Email

g167_0@kagome.co.jp

Institute

KAGOME CO., LTD.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Review Team
Professor Hiroharu Kamioka, Department of Ecological Symbiotic Science, Tokyo University of Agriculture
Ms. Satoko Shindo, Center for Academic Resources, St. Luke's International University.
Mr. Yudai Aoki, Innovation Division, KAGOME CO., LTD.
Dr. Kazutaka Yoshida, Innovation Division, KAGOME CO., LTD.
Mr. Shingo Takahashi, Innovation Division, KAGOME CO., LTD.

Name of secondary funder(s)

Organization

Kagome Ethics Committee

Address

3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan

Tel

03-5623-8501

Email

toshika_okuni@kagome.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2020

Year

06

Month

29

Day

Date of IRB

2020

Year

06

Month

29

Day

Anticipated trial start date

2020

Year

06

Month

29

Day

Last follow-up date

2021

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Searches)
An author (e.g., SS) will search 16 databases for studies from the beginning of each database to the search date.


(Data extraction)
Two authors (e.g., YA and KY) will independently apply all criteria to the full text of articles that have passed the first eligibility screening. Then they will independently extract data from the included studies and cross-check the data.

(Risk of bias assessment)
In order to ensure that variation is not caused by systematic errors in the study or execution, two authors (e.g., YA and KY) will independently assess the quality of articles. A full quality appraisal of these papers will be made using modified check list (13 items) of Cochrane Handbook for interventional trials. We will exclude papers with high risk of bias.

Disagreement and uncertainties will be resolved by discussion with another author (e.g., ST). In addition, we will calculate agreement rate and kappa coefficient.

(Inconsistency evaluation)
We will evaluate inconsistency of evidence according to the value of I square for heterogeneity of effect estimates in a meta-analysis.



(Imprecision assessment)
We will assess imprecision based on the total number of participants in all included studies.


(Meta-analysis)
Only when we will not find heterogeneity in RCT-P, RCT-C, qRCT-P, qRCT-C, nonRCT-P, nonRCT-C, and non-randomized controlled trials, YA will conduct a meta-analysis. If we will find missing data, we will make contact with the author to obtain the data.
We will assess heterogeneity according to the value of I square in Forest plot and assess publication bias using Funnel plot.
We will conduct sensitivity analysis and subgroup analyses in the case we judge to need them from results.

This is a systematic review protocol and has not been reviewed by IRB.

Registered date

2020

Year

06

Month

29

Day

Last modified on

2023

Year

02

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046755