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

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Caltrate® 600 + D

Weight loss intervention

About this trial

This is an interventional treatment trial for Obesity focused on measuring Caltrate, Lipoproteins, Glucose, Insulin, Blood pressure, Body fat, Body weight, Women, Diet, Macronutrients

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Université Laval

Outcomes

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

Full Information

NCT ID

NCT00353054

First Posted

July 14, 2006

Last Updated

July 14, 2006

Sponsor

Laval University

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00353054

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2002

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Laval University

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

Caltrate, Lipoproteins, Glucose, Insulin, Blood pressure, Body fat, Body weight, Women, Diet, Macronutrients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Caltrate® 600 + D

Intervention Type

Behavioral

Intervention Name(s)

Weight loss intervention

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention

Title

Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angelo Tremblay, PhD

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Université Laval

City

Quebec

ZIP/Postal Code

G1K 7P4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19263591

Citation

Major GC, Alarie FP, Dore 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. doi: 10.1017/s0007114508030808.

Results Reference

derived

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

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