UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040966
Receipt number R000046773
Scientific Title A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females
Date of disclosure of the study information 2020/07/19
Last modified on 2023/01/27 09:57:55

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Basic information

Public title

A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females

Acronym

A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females

Scientific Title

A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females

Scientific Title:Acronym

A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of lactoferrin on bone mineral density

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bone mineral density (lumber spine (L2-L4), proximal femur)

Key secondary outcomes

Blood analysis (BAP, TRACP-5b, NTX)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 24 weeks

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



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit

69 years-old >=

Gender

Female

Key inclusion criteria

1) Females aged 50-69 years who experienced natural menopause over a year ago
2) Subjects whose levels of bone mineral density measurement are more than Young Adult Mean (YAM) -2.5 SD and less than YAM -1.0 SD
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects receiving medical treatments for osteoporosis
2) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine, metabolic disorders or a medical history of these disorders
3) Subjects who take regularly pharmaceuticals and quasi-drugs which have the efficacy for bone mineral density or bone metabolism
4) Subjects who take regularly Foods for Specified Health Uses, Foods with Function Claims and supplements which have the possibility of the effects on bone mineral density or bone metabolism
5) Subjects who have the possibility of developing allergic symptoms by the test food
6) Subjects having blood sample of 200 ml or more taken within one month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
7) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
8) Subjects deemed unsuitable by the investigator

Target sample size

8


Research contact person

Name of lead principal investigator

1st name Megumi
Middle name
Last name Ohno

Organization

NRL Pharma, Inc.

Division name

Healthcare R&D Div.

Zip code

213-0012

Address

East Block #203, Kanagawa Science Park, 3-2-1, Sakado, Takatsu-Ku, Kawasaki-City, Kanagawa

TEL

044-850-9761

Email

ohno@nrl-pharma.co.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code

560-0082

Address

Senri Life Science Center 13F, 1-4-2 Shinsenri-higashimachi, Toyonaka-City, Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

NRL Pharma, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Fukuda Clinic

Address

Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-Ku, Osaka-City, Osaka

Tel

06-6398-0203

Email

fukudaclinicIRB@gmail.com


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



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 19 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

2020 Year 06 Month 20 Day

Date of IRB

2020 Year 06 Month 20 Day

Anticipated trial start date

2020 Year 07 Month 19 Day

Last follow-up date

2021 Year 03 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 01 Day

Last modified on

2023 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name