ObesityPhase 4NCT01447433
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
A Phase 4 study testing Calcium Carbonate and Energy restriction in people with Obesity and Overweight, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Calcium Carbonate and Energy restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 25 years of age, generally healthy
- Habitual calcium intake below 600mg/d
- Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)
- Stable body weight (body weight change less than 1kg two months before screening)
- Less than 3 times of 20min of physical exercise per week
- Signed written informed consent
Who cannot join
- Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment
- Pregnant or lactating woman
- Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization
- Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)
- On special diets (i.e. vegetarian)
- Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication)
Show all 9Show fewer
- Participating in another clinical trial 6 months before randomization
- Unlikely to be compliant (i.e. alcohol, drug abuse)
- Refusal or inability to give informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel Groups-controlled Clinical Trial to Evaluate the Effect of Calcium Plus Vitamin D Supplementation on Weight Management in Overweight and Obese Very-low Calcium Consumers
The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.
Read the detailed description
Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(<600mg/day).
The hypotheses to be tested are:
Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.
- Conditions
- Obesity, Overweight
- Being tested
- Calcium Carbonate, Energy restriction
- Keywords
- Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Obesity, Overweight
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDrug
Also called Caltrate® 600 + D, Code:1007300
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
Energy restrictionBehavioural
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
| Study group | Role | What they receive |
|---|---|---|
| Calcium+D | Experimental | Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. Receives: Drug: Calcium Carbonate; Behavioral: Energy restriction |
| Control | Placebo comparator | A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. Receives: Behavioral: Energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.
Measured: Baseline and 12 weeks
Secondary outcomes (9)
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.
Measured: Baseline and 12 weeks
Change in Fat Percentage
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
Measured: Baseline and 12 weeks
Change in Visceral Fat Area
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
Measured: Baseline and 12 weeks
Change in Waist, Abdominal and Hip Circumference
Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm
Measured: Baseline and 12 weeks
Change in Blood Pressure
Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.
Measured: Baseline and 12 weeks
Change in Lipid-lipoprotein Profile
Measured: Baseline and 12 weeks
Change in Fasting Plasma Glucose
Measured: Baseline and 12 weeks
Change in Fasting Plasma Insulin
Measured: Baseline and 12 weeks
Change in Energy Intakes
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Changhai HospitalThe 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donglian Cai, Changhai Hospital
- Investigators
- Donglian Cai, Master, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447433
- Sponsor's protocol ID
- 201011Z-02
- Status last verified
- Jul 2012
- First submitted
- 4 Oct 2011
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013 Jan 8;12:8. doi: 10.1186/1475-2891-12-8.
PubMed 23297844
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Groups-controlled Clinical Trial to Evaluate the Effect of Calcium Plus Vitamin D Supplementation on Weight Management in Overweight and Obese Very-low Calcium Consumers
- ClinicalTrials.gov ID
- NCT01447433
- Acronym / sponsor ID
- 201011Z-02
- Conditions
- Obesity, Overweight
- Keywords
- Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.
Detailed description
Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(<600mg/day).
The hypotheses to be tested are:
Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium+D | Experimental | Drug: Calcium Carbonate, Behavioral: Energy restrictionCalcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
| Control | Placebo comparator | Behavioral: Energy restrictionA balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female 18 to 25 years of age, generally healthy
- Habitual calcium intake below 600mg/d
- Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)
- Stable body weight (body weight change less than 1kg two months before screening)
- Less than 3 times of 20min of physical exercise per week
Key exclusion criteria (9 listed)
- Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment
- Pregnant or lactating woman
- Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization
- Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)
- On special diets (i.e. vegetarian)
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 |
|---|---|---|
| Calcium CarbonateAlso: Caltrate® 600 + D, Code:1007300tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks | Drug | Calcium+D |
| Energy restrictionA balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. | Behavioural | Calcium+D, Control |
Primary outcome
Change in Body Weight
Time frame: Baseline and 12 weeks
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.
9 secondary outcomes
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass
Time frame: Baseline and 12 weeks
Change in Fat Percentage
Time frame: Baseline and 12 weeks
Change in Visceral Fat Area
Time frame: Baseline and 12 weeks
Change in Waist, Abdominal and Hip Circumference
Time frame: Baseline and 12 weeks
Change in Blood Pressure
Time frame: Baseline and 12 weeks
Change in Lipid-lipoprotein Profile
Time frame: Baseline and 12 weeks
Change in Fasting Plasma Glucose
Time frame: Baseline and 12 weeks
Change in Fasting Plasma Insulin
Time frame: Baseline and 12 weeks
Change in Energy Intakes
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23297844Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013 Jan 8;12:8. doi: 10.1186/1475-2891-12-8.
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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.
Donglian Cai, Master principal investigator
Changhai Hospital
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 Calcium Carbonate and Energy restriction in people with Obesity and Overweight, run by Changhai Hospital at 1 site in China.
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 6 inclusion and 9 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 1 Aug 2012. 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 China. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Weight (time frame: Baseline and 12 weeks). 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 NCT01447433, 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 1 Aug 2012.