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Completed

NCT Number: NCT00353054

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

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

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Université Laval

Québec, Quebec, G1K 7P4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caltrate® 600 + D

Drug

Weight loss intervention

Behavioral

Primary outcomes

  1. Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study 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.

Important dates

Study start
2003
Study completion
2005
First posted
Jul 17, 2006
Registry last updated
Jul 17, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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