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

This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Laval University Identifier:
First received: July 14, 2006
Last updated: NA
Last verified: November 2002
History: No changes posted
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 Intervention Phase
Obesity Overweight Drug: Caltrate® 600 + D Behavioral: Weight loss intervention Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Laval University:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: January 2003
Estimated Study Completion Date: July 2005
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.

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

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
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Please refer to this study by its identifier: NCT00353054

Université Laval
Quebec, Canada, G1K 7P4
Sponsors and Collaborators
Laval University
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Angelo Tremblay, PhD Laval University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00353054     History of Changes
Other Study ID Numbers: CL-02-01
Study First Received: July 14, 2006
Last Updated: July 14, 2006

Keywords provided by Laval University:
Blood pressure
Body fat
Body weight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Vitamin D
Calcium Carbonate
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on September 20, 2017