ObesityPhase 3NCT00030238
Supplemental Calcium in Overweight People
A Phase 3 study testing Calcium supplement in people with Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will examine the health effects of calcium supplements in overweight adults. Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake in people who have some of the medical problems often seen in overweight adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Calcium supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2002to 14 Dec 2007
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers will qualify if they meet the following criteria:
- Good general health. Individuals taking medication for obesity-related co-morbid conditions will not be excluded.
- Age greater than or equal to 18 years.
- Body Mass Index greater than or equal to 25 kg/m(2).
- For women with childbearing potential, a negative pregnancy test at the initial evaluation.
- Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorous levels (2.3 - 4.3 mg/dl).
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- Volunteers will qualify if the meet the following criteria
- Good general health.
- Age greater than or equal to 18 years.
- Body Mass Index 1-24.99 kg/m(2)
- For women with childbearing potential, a negative pregnancy test at the initial evaluation. Since these subjects have to undergo DXA (dual Energy X-ray Absorptiometry) scan screening in their second visit, for safety purposes, pregnant women will be excluded from participation in the study.
- Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorus levels (2.3-4.3 mg/dl).
Who cannot join
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
- A presence of major illnesses: renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication or sleep-apnea related disorders);
- Women who are pregnant, or who are currently nursing an infant; or who are having unprotected intercourse;
- Individuals who have a current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study;
- Subjects who regularly use prescription medications unrelated to the complications of obesity {e.g., calcium channel blockers, diuretics (including thiazide diuretics), beta-blockers etc}. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter medications will be reviewed on a case-by -case basis;
- Subjects who have a total calcium intake of more than 3.5 g/day on the screening calcium intake questionnaire (SCQ) or more than 3 g/day of total calcium intake on review of their 7-day food diaries;
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- Subjects who take supplement calcium in excess of 300 mg/day or vitamin D supplements in excess of 400 IU/day;
- Recent (3 months) use of anorexiant medications;
- History of renal stones;
- Intentional weight change of more than 3% of body weight in the past two months.
- Post-menopausal women who are medically advised to take calcium supplementation.
- Subjects with iPTH greater than 75 pg/ml (Normal range: 10-75 pg/ml) when associated with a serum calcium level greater than 2.5 mmol/L. (normal range 2.05 to 2.55 mmol/L)
- Subjects with a serum 25-(OH)-D level less than 10 ng/ml (Normal range: 10-68 ng/ml) when associated with a serum 1-225-(OH)(2)-D level of less than 22 pg/ml (Normal Range: 22-67 pg/ml.
- Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg.
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
- Presence of major illnesses: renal (serum creatinine greater than 1.6), hepatic (AST/ALT greater than 3 times upper limit of normal range used in Clinical Center assays), gastrointestinal, most endocrinologic (e.g. Cushing syndrome, hyper- or hyothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication or sleep-apnea related disorders);
- Women who are pregnant, or who are currently nursing an infant;
- Individuals who have current substance abuse of a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study;
- Subjects who regularly use prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. Individuals taking medications for most conditions will be excluded, but medication use will be considered on a case-by-case basis.
- Subjects who take supplemental calcium in excess of 300 mg/day or vitamin D supplements in excess of 400 IU/day.
- Recent (3 months) use of anorexiant medications;
- Intentional weight change of more than 3% of body weight
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Supplemental Calcium in Overweight Out-Patients
This study will examine the health effects of calcium supplements in overweight adults. Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake in people who have some of the medical problems often seen in overweight adults. This study will see if extra calcium improves the health of overweight adults.
Volunteers in general good health 18 years of age or older who are overweight (body mass index equal to or greater than 25 kilograms per square meter of body surface) may be eligible for this study. Women who are pregnant or breastfeeding may not participate. The study includes four visits, described below.
Read more
Visit 1
Volunteers will be screened for participation in the study with a medical history, physical examination, and blood and urine tests. At home, they will collect a 24-hour urine sample; fill out questionnaires to assess their average calcium intake; and record their food intake for 7 days. Those enrolled in the study will continue with the next 3 visits.
Visit 2
Participants will complete a physical activity questionnaire, have their food diary reviewed, and meet with a dietitian for nutritional counseling. Triceps fold thickness and waist and hip circumferences will be measured three times. Body composition will be analyzed by a DEXA study. For this procedure, the subject lies on a flat table while a small dose of X-rays is passed through the body.
Participants will be randomly assigned to take either calcium carbonate (1500 mg/day) or placebo capsules twice a day by mouth for 2 years. (The placebo looks like the calcium capsules but contains no calcium.) They will receive a 6-month supply of study capsules during visit 2 and return to NIH every 6 months for the next supply. They will also be sent questionnaires by mail every 3 months to complete information about health problems and how often the study capsules are being taken.
Visits 3 and 4
Visit 3 is scheduled after participants have taken the study capsules for 1 year; visit 4 is scheduled after 2 years (the end of the study). At each of these visits, participants will have a DEXA scan, blood and urine tests, blood pressure measurements, and measurements of height, weight, waist and hip circumference. They will complete questionnaires about their medical history, side effects of the study medications, dietary calcium intake, and physical activity, and they will meet with one of the study investigators to talk about any concerns regarding the study. At the fourth visit, participants will answer some additional questions about their study participation and return the Diet History Questionnaire that was mailed to them before the visit.
Read the detailed description
An estimated 97 million people in the United States are overweight or obese, and therefore have an increased risk for a number of other obesity-related co-morbid conditions (such as hypertension, dyslipidemia, and Type 2 Diabetes) as well as for all-cause mortality. The total cost attributable to obesity amounted to $99.2 billion in the US in 1995 and this figure, like the prevalence of increased body mass, is rising at an alarming rate. At the same time calcium intake in the US adult population is far below the RDA (recommended daily allowance) and much below the daily optimal calcium intake recommended by the 1994 NIH consensus conference. An analysis of the NHANES III database suggests a strong inverse association between relative risk of obesity and calcium intake. Further, both prospective studies in animal models, and retrospective analyses of human studies suggest calcium supplementation may play a role in minimizing yearly weight gain, and may possibly induce small weight losses.
In order to test the relationship between calcium intake and body weight, we propose to conduct a 2-year, randomized, double-blind, placebo-controlled trial of calcium supplementation (1500 mg/day of supplementary calcium vs. placebo) in adults with a BMI greater than or equal to 25 kg/m(2). We will study the effects of supplemental calcium on body weight, body composition, and obesity-related comorbid conditions, such as insulin sensitivity and lipids. The effects of such supplementation on blood pressure will also be systematically evaluated. A control group of untreated, healthy, adults will also be enrolled for comparisons to study subjects.
- Conditions
- Obesity
- Being tested
- Calcium supplement, Placebo
- Keywords
- Body Fat, Weight Gain, Adult, Hypertension, Dietary Supplements, Healthy Volunteer, HIV, Body Weight
- Medical subject headings
- Obesity, Weight Gain, Hypertension, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium supplementDrug
Calcium Carbonate capsules prepared by NIH PDS
PlaceboDrug
Placebo capsules prepared by the NIH PDS to be identical to Calcium Carbonate capsules
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Other | Subjects take calcium twice daily with meals Receives: Drug: Calcium supplement |
| Control | Other | Subjects take placebo twice daily with meals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary research outcome will be change in body weight obtained from the calibrated scale measurements between the calcium-supplemented group versus the placebo treated group.
Measured: 2 years
Secondary outcomes (1)
Secondary outcomes will be triceps skinfold fold thickness, body circumferences and DXA percentage fat measurements between the calcium-supplemented group versus the placebo treated group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2002 (estimated)
- Study start6 Feb 2002
- Primary completion14 Dec 2007
- Study completion14 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030238
- Sponsor's protocol ID
- 020100
- Other IDs
- 02-CH-0100
- Status last verified
- 28 Oct 2014
- First submitted
- 12 Feb 2002
- Last updated
- 22 Nov 2019
- Results posted
- No
Publications
Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8.
PubMed 10834935Shi H, Halvorsen YD, Ellis PN, Wilkison WO, Zemel MB. Role of intracellular calcium in human adipocyte differentiation. Physiol Genomics. 2000 Aug 9;3(2):75-82. doi: 10.1152/physiolgenomics.2000.3.2.75.
PubMed 11015602Fleming KH, Heimbach JT. Consumption of calcium in the U.S.: food sources and intake levels. J Nutr. 1994 Aug;124(8 Suppl):1426S-1430S. doi: 10.1093/jn/124.suppl_8.1426S.
PubMed 8064396Manoli I, Sysol JR, Head PE, Epping MW, Gavrilova O, Crocker MK, Sloan JL, Koutsoukos SA, Wang C, Ktena YP, Mendelson S, Pass AR, Zerfas PM, Hoffmann V, Vernon HJ, Fletcher LA, Reynolds JC, Tsokos MG, Stratakis CA, Voss SD, Chen KY, Brown RJ, Hamosh A, Berry GT, Chen XS, Yanovski JA, Venditti CP. Lipodystrophy in methylmalonic acidemia associated with elevated FGF21 and abnormal methylmalonylation. JCI Insight. 2024 Feb 22;9(4):e174097. doi: 10.1172/jci.insight.174097.
PubMed 38271099Demidowich AP, Parikh VJ, Dedhia N, Branham RE, Madi SA, Marwitz SE, Roberson RB, Uhlman AJ, Levi NJ, Mi SJ, Jun JY, Broadney MM, Brady SM, Yanovski JA. Associations of the melanocortin 3 receptor C17A + G241A haplotype with body composition and inflammation in African-American adults. Ann Hum Genet. 2019 Sep;83(5):355-360. doi: 10.1111/ahg.12315. Epub 2019 Apr 2.
PubMed 30937899Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.
PubMed 29718281Yanovski JA, Parikh SJ, Yanoff LB, Denkinger BI, Calis KA, Reynolds JC, Sebring NG, McHugh T. Effects of calcium supplementation on body weight and adiposity in overweight and obese adults: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):821-9, W145-6. doi: 10.7326/0003-4819-150-12-200906160-00005.
PubMed 19528561
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Calcium in Overweight Out-Patients
- ClinicalTrials.gov ID
- NCT00030238
- Acronym / sponsor ID
- 020100
- Conditions
- Obesity
- Keywords
- Body Fat, Weight Gain, Adult, Hypertension, Dietary Supplements, Healthy Volunteer, HIV, Body Weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- 6 Feb 2002
- Primary completion
- 14 Dec 2007 (actual)
- Study completion
- 14 Dec 2007 (actual)
- First posted
- 12 Feb 2002 (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.
This study will examine the health effects of calcium supplements in overweight adults. Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake in people who have some of the medical problems often seen in overweight adults. This study will see if extra calcium improves the health of overweight adults.
Volunteers in general good health 18 years of age or older who are overweight (body mass index equal to or greater than 25 kilograms per square meter of body surface) may be eligible for this study. Women who are pregnant or breastfeeding may not participate. The study includes four visits, described below.
Visit 1
Volunteers will be screened for participation in the study with a medical history, physical examination, and blood and urine tests. At home, they will collect a 24-hour urine sample; fill out questionnaires to assess their average calcium intake; and record their food intake for 7 days. Those enrolled in the study will continue with the next 3 visits.
Visit 2
Participants will complete a physical activity questionnaire, have their food diary reviewed, and meet with a dietitian for nutritional counseling. Triceps fold thickness and waist and hip circumferences will be measured three times. Body composition will be analyzed by a DEXA study. For this procedure, the subject lies on a flat table while a small dose of X-rays is passed through the body.
Participants will be randomly assigned to take either calcium carbonate (1500 mg/day) or placebo capsules twice a day by mouth for 2 years. (The placebo looks like the calcium capsules but contains no calcium.) They will receive a 6-month supply of study capsules during visit 2 and return to NIH every 6 months for the next supply. They will also be sent questionnaires by mail every 3 months to complete information about health problems and how often the study capsules are being taken.
Visits 3 and 4
Visit 3 is scheduled after participants have taken the study capsules for 1 year; visit 4 is scheduled after 2 years (the end of the study). At each of these visits, participants will have a DEXA scan, blood and urine tests, blood pressure measurements, and measurements of height, weight, waist and hip circumference. They will complete questionnaires about their medical history, side effects of the study medications, dietary calcium intake, and physical activity, and they will meet with one of the study investigators to talk about any concerns regarding the study. At the fourth visit, participants will answer some additional questions about their study participation and return the Diet History Questionnaire that was mailed to them before the visit.
Detailed description
An estimated 97 million people in the United States are overweight or obese, and therefore have an increased risk for a number of other obesity-related co-morbid conditions (such as hypertension, dyslipidemia, and Type 2 Diabetes) as well as for all-cause mortality. The total cost attributable to obesity amounted to $99.2 billion in the US in 1995 and this figure, like the prevalence of increased body mass, is rising at an alarming rate. At the same time calcium intake in the US adult population is far below the RDA (recommended daily allowance) and much below the daily optimal calcium intake recommended by the 1994 NIH consensus conference. An analysis of the NHANES III database suggests a strong inverse association between relative risk of obesity and calcium intake. Further, both prospective studies in animal models, and retrospective analyses of human studies suggest calcium supplementation may play a role in minimizing yearly weight gain, and may possibly induce small weight losses.
In order to test the relationship between calcium intake and body weight, we propose to conduct a 2-year, randomized, double-blind, placebo-controlled trial of calcium supplementation (1500 mg/day of supplementary calcium vs. placebo) in adults with a BMI greater than or equal to 25 kg/m(2). We will study the effects of supplemental calcium on body weight, body composition, and obesity-related comorbid conditions, such as insulin sensitivity and lipids. The effects of such supplementation on blood pressure will also be systematically evaluated. A control group of untreated, healthy, adults will also be enrolled for comparisons to study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Other | Drug: Calcium supplementSubjects take calcium twice daily with meals |
| Control | Other | Drug: PlaceboSubjects take placebo twice daily with meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Good general health. Individuals taking medication for obesity-related co-morbid conditions will not be excluded.
- Age greater than or equal to 18 years.
- Body Mass Index greater than or equal to 25 kg/m(2).
- For women with childbearing potential, a negative pregnancy test at the initial evaluation.
- Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorous levels (2.3 - 4.3 mg/dl).
Key exclusion criteria (22 listed)
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
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 supplementCalcium Carbonate capsules prepared by NIH PDS | Drug | Active Treatment |
| PlaceboPlacebo capsules prepared by the NIH PDS to be identical to Calcium Carbonate capsules | Drug | Control |
Primary outcome
Primary research outcome will be change in body weight obtained from the calibrated scale measurements between the calcium-supplemented group versus the placebo treated group.
Time frame: 2 years
1 secondary outcome
Secondary outcomes will be triceps skinfold fold thickness, body circumferences and DXA percentage fat measurements between the calcium-supplemented group versus the placebo treated group.
Time frame: 2 years
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 22 Nov 2019.
- Background: PubMed 10834935Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8.
- Background: PubMed 11015602Shi H, Halvorsen YD, Ellis PN, Wilkison WO, Zemel MB. Role of intracellular calcium in human adipocyte differentiation. Physiol Genomics. 2000 Aug 9;3(2):75-82. doi: 10.1152/physiolgenomics.2000.3.2.75.
- Background: PubMed 8064396Fleming KH, Heimbach JT. Consumption of calcium in the U.S.: food sources and intake levels. J Nutr. 1994 Aug;124(8 Suppl):1426S-1430S. doi: 10.1093/jn/124.suppl_8.1426S.
- Derived from this study: PubMed 38271099Manoli I, Sysol JR, Head PE, Epping MW, Gavrilova O, Crocker MK, Sloan JL, Koutsoukos SA, Wang C, Ktena YP, Mendelson S, Pass AR, Zerfas PM, Hoffmann V, Vernon HJ, Fletcher LA, Reynolds JC, Tsokos MG, Stratakis CA, Voss SD, Chen KY, Brown RJ, Hamosh A, Berry GT, Chen XS, Yanovski JA, Venditti CP. Lipodystrophy in methylmalonic acidemia associated with elevated FGF21 and abnormal methylmalonylation. JCI Insight. 2024 Feb 22;9(4):e174097. doi: 10.1172/jci.insight.174097.
- Derived from this study: PubMed 30937899Demidowich AP, Parikh VJ, Dedhia N, Branham RE, Madi SA, Marwitz SE, Roberson RB, Uhlman AJ, Levi NJ, Mi SJ, Jun JY, Broadney MM, Brady SM, Yanovski JA. Associations of the melanocortin 3 receptor C17A + G241A haplotype with body composition and inflammation in African-American adults. Ann Hum Genet. 2019 Sep;83(5):355-360. doi: 10.1111/ahg.12315. Epub 2019 Apr 2.
- Derived from this study: PubMed 29718281Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.
- Derived from this study: PubMed 19528561Yanovski JA, Parikh SJ, Yanoff LB, Denkinger BI, Calis KA, Reynolds JC, Sebring NG, McHugh T. Effects of calcium supplementation on body weight and adiposity in overweight and obese adults: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):821-9, W145-6. doi: 10.7326/0003-4819-150-12-200906160-00005.
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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.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium supplement in people with Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 12 inclusion and 22 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 22 Nov 2019. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary research outcome will be change in body weight obtained from the calibrated scale measurements between the calcium-supplemented group versus the placebo treated group. (time frame: 2 years). 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 NCT00030238, which also lists 7 linked publications.
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 22 Nov 2019.