UMIN-ICDS Clinical Trial

Public title

An observational study with subjects in the same age group

Acronym

Association between vitamin D and bone mineral density in premenopausal female football players

Scientific Title

A cross sectional study

Scientific Title:Acronym

Vitamin D levels and bone mineral density of middle-aged premenopausal female football players: A cross-sectional study

Region

Japan

Condition

Premenopausal woman

Classification by specialty

Orthopedics	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to investigate the differences of vitamin D levels and bone mineral density in pre-menopausal women with and without continuous exercise.

Basic objectives2

Others

Basic objectives -Others

To investigate the association between exercise, vitamin D and bone mineral density.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Vitamin D levels
Bone mineral density

Key secondary outcomes

Study type

Observational

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

40

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Female

Key inclusion criteria

This study is conducted in Japan. In addition, participants who fulfil the following conditions
The participants who regularly play football
The participants who regularly play volleyball
The participants who do not regularly play sports

Key exclusion criteria

If participants are taking medicines or supplements that affect calcium or vitamin D metabolism
If participants suffer from diseases such as collagen diseases or malignant tumors
If participants may be pregnant

Target sample size

90

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Yoshimura

Organization

Juntendo University

Division name

Postgraduate of Health and Sports Science

Zip code

270-1695

Address

1-1 Hirakagakuenndai Inzai Chiba

TEL

0476-98-1001

Email

msyoshi@juntendo.ac.jp

Name of contact person

1st name	Masashi
Middle name
Last name	Nagao

Organization

Juntendo University

Division name

Medical Technology Innovation Center

Zip code

113-8421

Address

2-1-1 Hong Bunkyo Tokyo

TEL

03-3813-3111

Homepage URL

Email

nagao@juntendo.ac.jp

Institute

Others

Institute

Department

Personal name

Organization

Others

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics committee in Juntendo University Graduate School of Health and Sports Science

Address

1-1 hirakagakuendai Inzai Chiba

Tel

0476-98-1001

Email

sc-kyomu@juntendo.ac.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

2024

Year

04

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

92

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

Completed

Date of protocol fixation

2022

Year

07

Month

01

Day

Date of IRB

2022

Year

07

Month

22

Day

Anticipated trial start date

2022

Year

07

Month

23

Day

Last follow-up date

2023

Year

12

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Methods:
The participants were premenopausal females in their 40s. We evaluated bone mineral density of the second to fourth lumbar vertebrae and femoral neck; serum 25-hydroxy vitamin D (25-OHD) levels, which is the indicator of body vitamin D stores; and body composition. In addition, we administered a questionnaire survey on exercise habits and lifestyle. Ninety-two participants were placed into three groups: the football group (n=27), volleyball group (n=40), and non-exercise group (n=25).
Results:
Bone mineral density was higher in the football and volleyball groups than in the non-exercise group. The volleyball group had a significantly higher bone mineral density of the lumbar spine and femoral neck than the non-exercise group. The football group had a significantly higher bone mineral density of the femoral neck than the non-exercise group. Serum 25-OHD levels were the highest in the football group and were significantly higher in the volleyball and non-exercise groups.
Conclusions:
The present study found that middle-aged premenopausal football players had higher body vitamin D levels and bone mineral densities than non-active females. These results suggest that playing football may contribute to the prevention of osteoporosis.

Registered date

2024

Year

04

Month

23

Day

Last modified on

2024

Year

04

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061930