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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353054
• Other study ID #: CL-02-01
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2006
• Last updated: July 14, 2006
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: November 2002
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Drug:
• Caltrate® 600 + D

Behavioral:
• Weight loss intervention

Locations

Country	Name	City	State
Canada	Université Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
Secondary	Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
Secondary	Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention