Chronic Kidney DiseaseNCT01161407
Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
A study testing 1500 mg/d elemental calcium as calcium carbonate in people with Chronic Kidney Disease, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- 1500 mg/d elemental calcium as calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2011
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital - Clinical Research Center
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- 1500 mg/d elemental calcium as calcium carbonate, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1500 mg/d elemental calcium as calcium carbonateDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo control for calcium carbonate, given in same capsule form as the calcium carbonate, 3 times per day with meals. Receives: Dietary Supplement: Placebo |
| 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. Receives: Dietary Supplement: 1500 mg/d elemental calcium as calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Balance
Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).
Measured: 2 weeks
Secondary outcomes (2)
Phosphorus Balance
Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.
Measured: 2 weeks
"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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
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 (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Purdue University
- Responsible party
- Principal investigator, Munro Peacock, Indiana University
- Investigators
- Munro Peacock, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161407
- Sponsor's protocol ID
- Genzyme - 0907-07
- Status last verified
- Jul 2014
- First submitted
- 12 Jul 2010
- Last updated
- 29 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 6422710Levin 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.
PubMed 17091124Kestenbaum 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.
PubMed 15615819Jackman 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.
PubMed 9250111Coburn 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.
PubMed 4275344Peacock 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.
PubMed 606428Weaver 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.
PubMed 7872222Natale 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.
PubMed 40576086Stremke 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.
PubMed 29921736Hill 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.
PubMed 23254903
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01161407
- Acronym / sponsor ID
- Genzyme - 0907-07
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Purdue University
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Posted 31 Jul 2013
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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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 | Dietary Supplement: 1500 mg/d elemental calcium as calcium carbonate500 mg elemental calcium as calcium carbonate given 3 times per day with meals for a total of 1500 mg/d elemental calcium. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| 1500 mg/d elemental calcium as calcium carbonate500 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. | Dietary supplement | Calcium Carbonate (Phosphate Binder) |
| PlaceboPlacebo for calcium carbonate in same capsule form. Given 3 times per day with meals for 21 days in conjunction with a controlled diet. | Dietary supplement | Placebo |
Primary outcome
Calcium Balance
Time frame: 2 weeks
Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).
2 secondary outcomes
Phosphorus Balance
Time frame: 2 weeks
"Bone Balance" From Calcium Kinetics
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6422710Francis 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.
- Background: PubMed 17091124Levin 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.
- Background: PubMed 15615819Kestenbaum 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.
- Background: PubMed 9250111Jackman 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.
- Background: PubMed 4275344Coburn 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.
- Background: PubMed 606428Peacock 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.
- Background: PubMed 7872222Weaver 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.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 29921736Stremke 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.
- Derived from this study: PubMed 23254903Hill 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.
- Pubmed entry of publication from this study.Link provided by the sponsor.
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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.
Munro Peacock, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1500 mg/d elemental calcium as calcium carbonate in people with Chronic Kidney Disease, run by Indiana University 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 7 inclusion and 8 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 29 Jul 2014. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2013). 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?
Calcium Balance (time frame: 2 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 NCT01161407, which also lists 10 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 29 Jul 2014.