UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027854
Receipt number R000027019
Scientific Title Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes
Date of disclosure of the study information 2017/06/22
Last modified on 2017/06/21 17:41:30

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Basic information

Public title

Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes

Acronym

Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures

Scientific Title

Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes

Scientific Title:Acronym

Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of combined intake of low-fat milk and vitamin D supplement on bone metabolism.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in bone metabolism markers after 6-month intervention

Key secondary outcomes

Stress fracture incidence rate
Bone mineral density
Bone marrow edema


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Healthy athletes are given a low-fat milk (200ml/day) and vitamin D supplement (1000IU/day) every day for 6 month.

Interventions/Control_2

Healthy athletes are life as usual.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

1. More than 15 years of age less than 30 years old
2. Healthy athletes
3. Be able to provide written informed consent

Key exclusion criteria

1. Subjects who are judged as unsuitable for the study by the investigator for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Fujita

Organization

Ritsumeikan University

Division name

Graduate School of Sport and Health Science

Zip code


Address

1-1-1 Noji-higashi, Kusatsu, Shiga

TEL

077-561-5229

Email

safujita@fc.ritsumei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Fujita

Organization

Ritsumeikan University

Division name

Graduate School of Sport and Health Science

Zip code


Address

1-1-1 Noji-higashi, Kusatsu, Shiga

TEL

077-561-5229

Homepage URL


Email

safujita@fc.ritsumei.ac.jp


Sponsor or person

Institute

Graduate School of Sport and Health Science, Ritsumeikan University

Institute

Department

Personal name



Funding Source

Organization

Japan Diary Association (J-milk), Dairy Products Health Science Council

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

立命館大学


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 07 Month 14 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 21 Day

Last modified on

2017 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name