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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
| Purdue University | OTHER |
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The purpose of this study is to gain a better understanding of calcium absorption and metabolism in patients with Chronic Kidney Disease (CKD) using calcium balance and kinetic methods.
The purpose of this study is to gain a better understanding of calcium absorption and metabolism in patients with Chronic Kidney Disease (CKD). It is important that the body get enough calcium to support many important body functions including bone health. CKD changes the calcium balance or how calcium is absorbed and excreted. Because of this, the knowledge of calcium absorption and excretion in patients with normal kidney function cannot be used to assess patients with CKD. In patients with CKD bone heath is often negatively affected due to a combination of poor calcium absorption, increased bone turnover (process where old bone is removed and new bone is formed), increased level of parathyroid hormone (PTH [ a hormone that acts to increase calcium in the blood]) and decrease in vitamin D levels. This negative effect is referred to as Chronic Kidney Disease Mineral Bone Disorder (CKD-MBD).
Treatment to correct CKD-MBD should begin early in the course of CKD. In the normal population calcium supplements are frequently used to help prevent age related bone loss. Calcium supplements can also be used in CKD patients to help bind phosphate. Maintaining correct levels of phosphate in the body is crucial in CKD. However, calcium supplements may have adverse effects by promoting calcium phosphate deposits in soft tissues like the vascular system which could increase the risk of cardiovascular disease.
Therefore this formal balance study is needed to determine if positive calcium balance occurs in patients with advanced CKD who are given calcium with meals as a phosphate binder. This study will also evaluate how the body handles phosphate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo control for calcium carbonate, given in same capsule form as the calcium carbonate, 3 times per day with meals. |
|
| Calcium Carbonate (Phosphate Binder) | Active Comparator | 500 mg elemental calcium as calcium carbonate given 3 times per day with meals for a total of 1500 mg/d elemental calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1500 mg/d elemental calcium as calcium carbonate | Dietary Supplement | 500 mg elemental calcium as calcium carbonate given 3 times per day with meals for a total of 1500 mg/d elemental calcium. Given for 21 days in conjunction with a controlled diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium Balance | Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphorus Balance | Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces. | 2 weeks |
| "Bone Balance" From Calcium Kinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Munro Peacock, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital - Clinical Research Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6422710 | Background | Francis RM, Peacock M, Barkworth SA. Renal impairment and its effects on calcium metabolism in elderly women. Age Ageing. 1984 Jan;13(1):14-20. doi: 10.1093/ageing/13.1.14. | |
| 17091124 | Background | Levin A, Bakris GL, Molitch M, Smulders M, Tian J, Williams LA, Andress DL. Prevalence of abnormal serum vitamin D, PTH, calcium, and phosphorus in patients with chronic kidney disease: results of the study to evaluate early kidney disease. Kidney Int. 2007 Jan;71(1):31-8. doi: 10.1038/sj.ki.5002009. Epub 2006 Nov 8. |
| Label | URL |
|---|---|
| Pubmed entry of publication from this study. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Then Placebo | Crossover order was calcium then placebo, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration. |
| FG001 | Placebo Then Calcium | Crossover order was placebo then calcium, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Then Placebo | Crossover order was calcium then placebo, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Calcium Balance | Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces). | Posted | Least Squares Mean | Standard Error | mg/d calcium | 2 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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Due to the characteristic short treatment periods of balance studies, the results may not reflect the effects of chronic treatment with calcium carbonate on mineral balance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen M. Hill Gallant | Purdue University | 765-494-0101 | hillgallant@purdue.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Placebo | Dietary Supplement | Placebo for calcium carbonate in same capsule form. Given 3 times per day with meals for 21 days in conjunction with a controlled diet. |
|
Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.
| 2 weeks |
| 15615819 | Background | Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, Sherrard DJ, Andress DL. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):520-8. doi: 10.1681/ASN.2004070602. Epub 2004 Dec 22. |
| 9250111 | Background | Jackman LA, Millane SS, Martin BR, Wood OB, McCabe GP, Peacock M, Weaver CM. Calcium retention in relation to calcium intake and postmenarcheal age in adolescent females. Am J Clin Nutr. 1997 Aug;66(2):327-333. doi: 10.1093/ajcn/66.2.327. |
| 4275344 | Background | Coburn JW, Hartenbower DL, Massry SG. Intestinal absorption of calcium and the effect of renal insufficiency. Kidney Int. 1973 Aug;4(2):96-104. doi: 10.1038/ki.1973.88. No abstract available. |
| 606428 | Background | Peacock M, Aaron JE, Walker GS, Davison AM. Bone disease and hyperparathyroidism in chronic renal failure: the effect of 1alpha-hydroxyvitamin D3. Clin Endocrinol (Oxf). 1977 Dec;7 Suppl:73s-81s. doi: 10.1111/j.1365-2265.1977.tb03365.x. No abstract available. |
| 7872222 | Background | Weaver CM, Martin BR, Plawecki KL, Peacock M, Wood OB, Smith DL, Wastney ME. Differences in calcium metabolism between adolescent and adult females. Am J Clin Nutr. 1995 Mar;61(3):577-81. doi: 10.1093/ajcn/61.3.577. |
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
| 29921736 | Derived | Stremke ER, McCabe LD, McCabe GP, Martin BR, Moe SM, Weaver CM, Peacock M, Hill Gallant KM. Twenty-Four-Hour Urine Phosphorus as a Biomarker of Dietary Phosphorus Intake and Absorption in CKD: A Secondary Analysis from a Controlled Diet Balance Study. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):1002-1012. doi: 10.2215/CJN.00390118. Epub 2018 Jun 19. |
| 23254903 | Derived | Hill KM, Martin BR, Wastney ME, McCabe GP, Moe SM, Weaver CM, Peacock M. Oral calcium carbonate affects calcium but not phosphorus balance in stage 3-4 chronic kidney disease. Kidney Int. 2013 May;83(5):959-66. doi: 10.1038/ki.2012.403. Epub 2012 Dec 19. |
| Placebo Then Calcium |
Crossover order was placebo then calcium, separated by at least a 3 week washout period. Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Phosphorus Balance | Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces. | Posted | Least Squares Mean | Standard Error | mg/d phosphorus | 2 weeks |
|
|
|
| Secondary | "Bone Balance" From Calcium Kinetics | Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling. | Posted | Least Squares Mean | Standard Error | mg/d calcium | 2 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Calcium | 0 | 6 | 0 | 6 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |