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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353054
Enrollment
80
Registered
2006-07-17
Start date
2003-01-31
Completion date
2005-07-31
Last updated
2006-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

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

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.

Interventions

DRUGCaltrate® 600 + D

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
CollaboratorINDUSTRY
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026