Protocol summary

Summary
The purpose of this research is to study the impact of short-term supplementation of thiamine pyrophosphate on aerobic and anaerobic power of soccer girls were. This study was a clinical trial sample of 20 young girls That the 200 girl soccer city Neyriz randomly selected. The design of the study was crossover ,double blind and randomized and it was conducted in 1390. After compleating the questionnaire, Bruce and Rast tests for primary assessment variables was two days before the start of supplementation. At the beginning of Rest test was perfor med two hours after Bruce test. Subjects after exposure and placebo groups for a week and placebo (twice daily at 8 Am and 4 Pm at 100 mg per does thiamine supplementation and calcium bicarbonate capsules as a placebo) received. After a test run first and supplementation 7-day period during the 10-day wash was applied. Subjects than received the first day of thiamine supplementation, versus the placebo group than in the placebo supplement, thiamine consumption.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014103014611N3
Registration date: 2014-11-28, 1393/09/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Tahereh Siahpour
Name of organization / entity
Islamic azad university fars scince and research branch
Country
Iran (Islamic Republic of)
Phone
+98 917 341 1404
Email address
nikbkht@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad niversity Fars Science And Research Branch
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-05-15, 1390/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thiamine effect on aerobic and anaerobic power
Public title
Thiamine effect on aerobic and anaerobic power
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:Girl: Young: Athlete: Healthy Girls Exclusion criteria:In the absence of test: Lack of thiamine supplementation: Girls less than 16 years
Age
From 17 years old to 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic azad university fars science and research branch
Street address
Dorodzan dam,18 km Marvdasht road,Fars province
City
Marvdasht
Postal code
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
481214048910116

Health conditions studied

1

Description of health condition studied
aerobic power
ICD-10 code
J98.8
ICD-10 code description
Other specified respiratory disorders

2

Description of health condition studied
anaerobic power
ICD-10 code
J98.8
ICD-10 code description
Other specified respiratory disorders

Primary outcomes

1

Description
Anaerobic power
Timepoint
Before the intervention, 24 days after the intervention
Method of measurement
Questionnaire Rast and Bruce

2

Description
Aerobic power
Timepoint
Before the intervention, 24 days after the intervention
Method of measurement
Questionnaire Rast and Bruce

Secondary outcomes

1

Description
Thiamine pyrophosphate
Timepoint
Before the intervention, 24 days after the intervention
Method of measurement
Questionnaire Rast and Bruce

2

Description
Calcium Bicarbonate Capsules
Timepoint
Before the intervention, 24 days after the intervention
Method of measurement
Questionnaire Rast and Bruce

Intervention groups

1

Description
Supplementation group (supplemental thiamine pyrophosphate) thiamine pyrophosphate for a week and daily supplements of 100 mg in the morning and afternoon
Category
Other

2

Description
Placebo group (calcium bicarbonate capsules) calcium bicarbonate capsules 100 mg two times a week, morning and afternoon.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ministry of Education, government office for Fars province
Full name of responsible person
Elaheh Sahragard
Street address
NO 20, Department of Education, Esteghlal Boulevard, Neiriz
City
Neiriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Fars Science And Research Branch
Full name of responsible person
Mr barkhordari and di bazargan
Street address
Dorodzan dam,18 km Marvdasht road,Fars province
City
Marvdasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Fars Science And Research Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ministry of Education
Full name of responsible person
Elaheh Sahragard
Position
MSc
Other areas of specialty/work
Street address
NO 17, Sub-prime, Boulevard commanders, Neyriz, Fars
City
Neyriz
Postal code
Phone
+98 74 9188 3567
Fax
Email
Ela_sahragard62@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ministry of Education
Full name of responsible person
Elaheh Sahragard
Position
MSc
Other areas of specialty/work
Street address
NO 17, Sub-prime, Boulevard commanders, Neyriz, Fars
City
Neyriz
Postal code
Phone
+98 74 9188 3567
Fax
Email
Ela_sahragard62@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Karaj Unit
Full name of responsible person
Shabestari Moeini Masoud
Position
Assistant, PhD in Exercise Physiology
Other areas of specialty/work
Street address
NO 6, Phase 4, Block 3, Ekbatan, Tehran
City
Karaj
Postal code
Phone
+98 26 3441 8146
Fax
Email
sdmoeini@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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