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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:
Collaborator:
University Hospital, Clermont-Ferrand
Information provided by:
Elvir SAS
ClinicalTrials.gov Identifier:
NCT00663221
First received: April 14, 2008
Last updated: July 3, 2009
Last verified: July 2009
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   50 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663221

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

No publications provided

ClinicalTrials.gov Identifier: NCT00663221     History of Changes
Other Study ID Numbers: LC2 Atlas
Study First Received: April 14, 2008
Last Updated: July 3, 2009
Health Authority: France: Direction Général de la Santé
France: Comité de Protection des Personnes

Keywords provided by Elvir SAS:
Osteoporosis prevention

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

ClinicalTrials.gov processed this record on June 18, 2013