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Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.

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.
 
ClinicalTrials.gov Identifier: NCT00353054
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : July 17, 2006
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Laval University

Study Description
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Brief Summary:
The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate 600 +D®) on body weight loss during a weight-reducing program

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Caltrate® 600 + D Behavioral: Weight loss intervention Phase 4

Detailed Description:

The effect of a calcium supplementation on body weight loss is inconclusive and some studies have suggested that adequate calcium intake can have a favourable effect on some metabolic variables. The objectives of this study were to evaluate the impact of (Caltrate 600 + D ®) on body composition and various indicators of metabolic health in overweight and obese females characterised by a usual low daily calcium intake, on a weight-reducing program.

The main hypotheses of this study were:

  • Caltrate 600 +D® increases body weight and fat mass losses of individuals on a weight-reducing program.
  • Caltrate 600 +D® improves the metabolic profile of these subjects, independently of variations promoted by body fat loss.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Calcium/Vitamin D Supplementation (Caltrate 600+ D) on Body Weight and Fat Loss in Overweight and Obese Individuals on a Weight-Reducing Program.
Study Start Date : January 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.

Secondary Outcome Measures :
  1. Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
  2. Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Daily calcium intake below 800mg/day
  • Stable body weight
  • Body mass index (BMI) between 27-40kg/m2
  • Less than 3 periods of 20 minutes of physical exercise/week
  • General good health
  • Normal blood pressure values
  • Normal cholesterol levels
  • Normal thyroid hormone levels
  • No participation in another clinical trial within 6 months of screening
  • Coffee consumption ≤ 5 cups/day.

Exclusion Criteria:

  • Breast feeding, pregnant or menopaused women
  • Use of calcium supplements within 30 days of screening
  • Cholesterol levels requiring pharmaceutical treatment
  • Smoking
  • Use of medication that could affect body weight
Contacts and Locations
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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): NCT00353054


Locations
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Canada
Université Laval
Quebec, Canada, G1K 7P4
Sponsors and Collaborators
Laval University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: Angelo Tremblay, PhD Laval University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00353054    
Other Study ID Numbers: CL-02-01
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: July 17, 2006
Last Verified: November 2002
Keywords provided by Laval University:
Caltrate
Lipoproteins
Glucose
Insulin
Blood pressure
 Body fat
Body weight
Women
Diet
Macronutrients
Additional relevant MeSH terms:
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Overweight
Body Weight
Overnutrition
Nutrition Disorders
 Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents