Study of the Osteoprotector Effects of a Milk Product Bas... | NCT00663221

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

NCT00663221

Sponsor

Elvir SAS

Status

Completed

Last Update Posted

Jul 7, 2009Estimated

Enrollment

56Estimated

Phase

Phase 2

Conditions

Osteoporosis

Interventions

Anthocyans, Calcium and Vitamin D
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 14, 2008

First Submission Date that Met QC Criteria

Apr 21, 2008

First Posted Date

Apr 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2009

Last Update Posted Date

Jul 7, 2009Estimated

Name	Class
University Hospital, Clermont-Ferrand	OTHER

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Dietary Supplement: placebo
2	Experimental		Dietary Supplement: Anthocyans, Calcium and Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anthocyans, Calcium and Vitamin D	Dietary Supplement		2
placebo

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63	France

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002118	Calcium
D014807	Vitamin D

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals

Browse Leaves

Not provided

Browse Branches

Not provided