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

Phase 4

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT00353054
• Lead Sponsor: Laval University

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

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 Timeline

• Status Verified: 2002-11
• Study Start: 2003-01
• Study Completion: 2005-07
• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-14
• Last Update Submitted: 2006-07-14
• Study First Posted: 2006-07-17
• Last Update Posted: 2006-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Université Laval; 🇨🇦 Quebec, Canada