Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
July 31, 2013
CompletedJuly 29, 2014
July 1, 2014
1.4 years
July 12, 2010
May 30, 2013
July 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Calcium Balance
Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).
2 weeks
Secondary Outcomes (2)
Phosphorus Balance
2 weeks
"Bone Balance" From Calcium Kinetics
2 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo control for calcium carbonate, given in same capsule form as the calcium carbonate, 3 times per day with meals.
Calcium Carbonate (Phosphate Binder)
ACTIVE COMPARATOR500 mg elemental calcium as calcium carbonate given 3 times per day with meals for a total of 1500 mg/d elemental calcium.
Interventions
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.
Placebo for calcium carbonate in same capsule form. Given 3 times per day with meals for 21 days in conjunction with a controlled diet.
Eligibility Criteria
You may qualify if:
- Patients with a GFR of \< 45 ml/min;
- Intact serum PTH \> 37 pg/ml;
- Age \> 35 years (both genders and all races);
- Able to perform two three-week balance studies;
- Not on oral calcium or vitamin D other than multi vitamin, or willing to stop calcium or vitamin D for one month prior to entry in the study (day 1 of first calcium balance period);
- Female patients must be post-menopausal (defined as last menstrual period at least 12 months prior to screening visit) or surgically sterile by hysterectomy;
- On stable doses of diuretics, bisphosphonates, anti-epileptics (except dilantin) for at least 2 months.
You may not qualify if:
- Serious underlying systemic disease (including uncontrolled diabetes, lupus, hypertension, amyloid, etc);
- Taking drugs that alter calcium and phosphate balance or homeostasis including high dose cholecalciferol or ergocalciferol (1000 U/day or 50,000U/ wk, respectively), active vitamin D metabolites, calcimimetics, PTH analogues in the last 30 days;
- Taking drugs that the investigator feels will alter calcium balance;
- Plan to initiate dialysis in the next six months;
- Hypercalcemia defined as serum calcium \> 10.5 mg/dl;
- Hyperphosphatemia defined as serum phosphate \>5.5mg/ml;
- Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, bariatric surgery;
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Genzyme, a Sanofi Companycollaborator
- Purdue Universitycollaborator
Study Sites (1)
Indiana University Hospital - Clinical Research Center
Indianapolis, Indiana, 46202, United States
Related Publications (10)
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.
PMID: 6422710BACKGROUNDLevin 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.
PMID: 17091124BACKGROUNDKestenbaum 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.
PMID: 15615819BACKGROUNDJackman 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.
PMID: 9250111BACKGROUNDCoburn 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.
PMID: 4275344BACKGROUNDPeacock 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.
PMID: 606428BACKGROUNDWeaver 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.
PMID: 7872222BACKGROUNDNatale 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.
PMID: 40576086DERIVEDStremke 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.
PMID: 29921736DERIVEDHill 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.
PMID: 23254903DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Kathleen M. Hill Gallant
- Organization
- Purdue University
Study Officials
- PRINCIPAL INVESTIGATOR
Munro Peacock, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 13, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
July 29, 2014
Results First Posted
July 31, 2013
Record last verified: 2014-07