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NCT00663221 Clinical Trial

Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00663221
Other study ID # LC2 Atlas
Secondary ID
Status Completed
Phase Phase 2
First received April 14, 2008
Last updated July 3, 2009
Start date March 2008

Study information
Verified date July 2009
Source Elvir SAS
Contact n/a
Is FDA regulated No
Health authority France: Direction Général de la SantéFrance: Comité de Protection des Personnes
Study type Interventional

Clinical Trial Summary

We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria:

- Women

- Aged between 50 and 65 years

- Between 1 and 5 years menopause

- IMC between 19 and 30 kg/m²

Exclusion Criteria:

- Medical Treatment for bone metabolism

- Vitamin D not including in the range of 20nmoles<25(OH)<100nmoles/l

- Vegan and vegetarian diet

- Regular consumption of food supplementary benefits

- Lactose intolerance

- While dieting

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Anthocyans, Calcium and Vitamin D

• placebo

Locations
Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (2)
Lead Sponsor Collaborator
Elvir SAS University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

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