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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00353054
First received: July 14, 2006
Last updated: NA
Last verified: November 2002
History: No changes posted

July 14, 2006
July 14, 2006
January 2003
Not Provided
Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
Same as current
No Changes Posted
  • Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
  • Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
Same as current
Not Provided
Not Provided
 
Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.
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.
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

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Drug: Caltrate® 600 + D
  • Behavioral: Weight loss intervention
Not Provided
Major GC, Alarie FP, Doré J, Tremblay A. Calcium plus vitamin D supplementation and fat mass loss in female very low-calcium consumers: potential link with a calcium-specific appetite control. Br J Nutr. 2009 Mar;101(5):659-63.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2005
Not Provided

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
Sexes Eligible for Study: Female
30 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00353054
CL-02-01
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Laval University
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Angelo Tremblay, PhD Laval University
Laval University
November 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP