NCT00663221

Brief Summary

We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

First QC Date

April 14, 2008

Last Update Submit

July 3, 2009

Conditions

Osteoporosis

Keywords

Osteoporosis prevention

Study Arms (2)

1

PLACEBO COMPARATOR
Dietary Supplement: placebo

2

EXPERIMENTAL
Dietary Supplement: Anthocyans, Calcium and Vitamin D

Interventions

Anthocyans, Calcium and Vitamin DDIETARY_SUPPLEMENT
2
placeboDIETARY_SUPPLEMENT
1

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Aged between 50 and 65 years
  • Between 1 and 5 years menopause
  • IMC between 19 and 30 kg/m²

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

CalciumVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 22, 2008

Study Start

March 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

FR(1)