Effect of Calcium/Vitamin D Supplementation on Body Weigh... | NCT00353054

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

NCT00353054

Sponsor

Laval University

Status

Completed

Last Update Posted

Jul 17, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Obesity
Overweight

Interventions

Caltrate® 600 + D
Weight loss intervention

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Jul 14, 2006

First Submission Date that Met QC Criteria

Jul 14, 2006

First Posted Date

Jul 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2006

Last Update Posted Date

Jul 17, 2006Estimated

Name	Class
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time 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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo Tremblay, PhD	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Université Laval		Québec	Quebec	G1K 7P4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19263591	Derived	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.

ID	Term
D009765	Obesity
D050177	Overweight
D007333	Insulin Resistance
D001835	Body Weight

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D012816	Signs and Symptoms