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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014