Clinical trial NCT00353054: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Overweight
Keywords: Caltrate
Lipoproteins
Glucose
Insulin
Blood pressure
Body fat
Body weight
Women
Diet
Macronutrients
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-07-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
Secondary outcomes:
measure: Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
measure: Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Université Laval
Study officials:
affiliation: Laval University
name: Angelo Tremblay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.