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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Anthocyans, Calcium and Vitamin D
placebo
Sponsored by
Elvir SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis prevention

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
July 3, 2009
Sponsor
Elvir SAS
Collaborators
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00663221
Brief Title
Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Elvir SAS
Collaborators
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Anthocyans, Calcium and Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63
Country
France

12. IPD Sharing Statement

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

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