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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663221
First Posted: April 22, 2008
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Clermont-Ferrand
Information provided by:
Elvir SAS
  Purpose
We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Condition Intervention Phase
Osteoporosis Dietary Supplement: Anthocyans, Calcium and Vitamin D Dietary Supplement: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Elvir SAS:

Estimated Enrollment: 56
Study Start Date: March 2008
Arms Assigned Interventions
Placebo Comparator: 1 Dietary Supplement: placebo
Experimental: 2 Dietary Supplement: Anthocyans, Calcium and Vitamin D

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663221


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63
Sponsors and Collaborators
Elvir SAS
University Hospital, Clermont-Ferrand
  More Information

ClinicalTrials.gov Identifier: NCT00663221     History of Changes
Other Study ID Numbers: LC2 Atlas
First Submitted: April 14, 2008
First Posted: April 22, 2008
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Elvir SAS:
Osteoporosis prevention

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents