ObesityPhase 4NCT00353054
Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.
A Phase 4 study testing Caltrate® 600 + D and Weight loss intervention in people with Obesity and Overweight, run by Laval University at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Caltrate® 600 + D and Weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2003to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Normal cholesterol levels
- Normal thyroid hormone levels
- No participation in another clinical trial within 6 months of screening
- Coffee consumption ≤ 5 cups/day.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Caltrate® 600 + D, Weight loss intervention
- Keywords
- Caltrate, Lipoproteins, Glucose, Insulin, Blood pressure, Body fat, Body weight, Women, Diet, Macronutrients
- Medical subject headings
- Obesity, Overweight, Insulin Resistance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caltrate® 600 + DDrug
Weight loss interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJan 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Angelo Tremblay, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353054
- Sponsor's protocol ID
- CL-02-01
- Status last verified
- Nov 2002
- First submitted
- 14 Jul 2006
- Last updated
- 17 Jul 2006
- Results posted
- No
Publications
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.
PubMed 19263591
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00353054
- Acronym / sponsor ID
- CL-02-01
- Conditions
- Obesity, Overweight
- Keywords
- Caltrate, Lipoproteins, Glucose, Insulin, Blood pressure, Body fat, Body weight, Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2003
- Study completion
- Jul 2005
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caltrate® 600 + D | Drug | – |
| Weight loss intervention | Behavioural | – |
Primary outcome
Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2006.
- Derived from this study: PubMed 19263591Major 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Tremblay, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caltrate® 600 + D and Weight loss intervention in people with Obesity and Overweight, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2006.