NCT00353054

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jan 2003

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
Last Updated

July 17, 2006

Status Verified

November 1, 2002

First QC Date

July 14, 2006

Last Update Submit

July 14, 2006

Conditions

ObesityOverweight

Keywords

CaltrateLipoproteinsGlucoseInsulinBlood pressureBody fatBody weightWomenDietMacronutrients

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

Caltrate® 600 + DDRUG
Weight loss interventionBEHAVIORAL

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Laval

Québec, Quebec, G1K 7P4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19263591DERIVED

MeSH Terms

Conditions

ObesityOverweightInsulin ResistanceBody Weight

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Angelo Tremblay, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

January 1, 2003

Study Completion

July 1, 2005

Last Updated

July 17, 2006

Record last verified: 2002-11

Locations

CA(1)