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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02369289
Other study ID # 0013-15-TLV
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 16, 2015
Last updated February 16, 2015
Start date March 2015

Study information

Verified date February 2015
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria:

- generaly healthy

- vegan group: vegan diet for the past 3 years

- omnivore group: comsumption of animal products at least 3 times a week

Exclusion Criteria:

- pragnent / breastfeeding women

- amenorrhea (absence of a menstrual period) for more than 3 months

- amenorrhea in the past

- significant underweight in the present/past (BMI < 17.5)

- taking medicine that affect bone density

- hypo/hyper thyroidism

- hypo/hyper parathyroidism

- smokimg in the past 10 years

- over consumption of alcohol (more than 7 units a week)

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Intervention

Other:
bone mineral density test


Locations

Country Name City State
Israel Clinical Nutrition Unit, Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary bone mineral density 1 day No
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