Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss. - Full Text View

Sponsors and Collaborators:	Laval University Wyeth
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00353054

Purpose

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Calcium Dietary Supplements Diets Obesity Weight Control

Drug Information available for: Calcium gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	30 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353054

Locations

Canada
Université Laval
Quebec, Canada, G1K 7P4

Sponsors and Collaborators

Laval University

Wyeth

Investigators

Principal Investigator:

Angelo Tremblay, PhD

Université Laval

More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Major GC, Alarie FP, Doré 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.

Study ID Numbers:	CL-02-01
Study First Received:	July 14, 2006
Last Updated:	July 14, 2006
ClinicalTrials.gov Identifier:	NCT00353054 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Caltrate
Lipoproteins
Glucose
Insulin
Blood pressure
Body fat

Body weight
Women
Diet
Macronutrients
Caltrate

Study placed in the following topic categories:

Body Weight
Calcium, Dietary
Signs and Symptoms
Obesity
Vitamin D
Vitamins

Nutrition Disorders
Antacids
Overnutrition
Overweight
Calcium Carbonate
Insulin

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Molecular Mechanisms of Pharmacological Action
Nutrition Disorders

Antacids
Overnutrition
Overweight
Calcium Carbonate
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009