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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 is currently recruiting participants.
Verified by Elvir SAS, April 2008
First Received: April 14, 2008   Last Updated: April 21, 2008   History of Changes
Sponsors and Collaborators: Elvir SAS
University Hospital, Clermont-Ferrand
Information provided by: Elvir SAS
ClinicalTrials.gov Identifier: NCT00663221
  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 II

MedlinePlus related topics: Calcium Dietary Supplements Diets Osteoporosis
Drug Information available for: Calcium gluconate Vitamin D
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Further study details as provided by Elvir SAS:

Estimated Enrollment: 56
Study Start Date: March 2008
Arms Assigned Interventions
1: Placebo Comparator Dietary Supplement: placebo
2: Experimental 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

Contacts
Contact: Claude Dubray 00 33 4 73 17 84 10 claude.dubray@u-clermont1.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63
Contact: Patrick Lacarin     00 33 4 73 75 11 95     placarin@chu-clermontferrand.fr    
Principal Investigator: Claude Dubray            
Sponsors and Collaborators
Elvir SAS
University Hospital, Clermont-Ferrand
  More Information

No publications provided

Study ID Numbers: LC2 Atlas
Study First Received: April 14, 2008
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00663221     History of Changes
Health Authority: France: Direction Général de la Santé;   France: Comité de Protection des Personnes

Keywords provided by Elvir SAS:
Osteoporosis prevention

Study placed in the following topic categories:
Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Vitamins
Osteoporosis
 Trace Elements
Bone Density Conservation Agents
Bone Diseases, Metabolic
Micronutrients
Bone Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009



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