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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547010
Other study ID # IRB-UGS-2018-03-273
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 12, 2018
Est. completion date March 15, 2019

Study information

Verified date September 2023
Source Imam Abdulrahman Bin Faisal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low bone mineral density (BMD) has recently increased among young women. Soy Isoflavone as a food supplement, has been found to have potent effect on bone health in postmenopausal women. However, the effect of soy isoflavone on pre-menopausal is not well understood. This research is done to examine the effect of soy isoflavones on BMD among young university female students.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date March 15, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - female - University students - aged between 18-25 years Exclusion Criteria: - Study participants who use medications and suffer from diseases that may interfere or effect on BMD, use calcium and vitamin D supplements and who suffer from glucose 6 phosphate deficiency (G6PD) were excluded from the study.

Study Design


Intervention

Dietary Supplement:
Soy Isoflavone supplement
Participants received 60 mg of soy-isoflavone supplement per day.

Locations

Country Name City State
Saudi Arabia Imam Abdulrahman Bin Faisal University Dammam Eastern

Sponsors (1)

Lead Sponsor Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone Mineral Density (BMD) 4 weeks
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