Clinical trial NCT01161407: Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Official title: Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: Purdue University
First posted: 2010-07-13
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with a GFR of \< 45 ml/min;
2. Intact serum PTH \> 37 pg/ml;
3. Age \> 35 years (both genders and all races);
4. Able to perform two three-week balance studies;
5. 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);
6. Female patients must be post-menopausal (defined as last menstrual period at least 12 months prior to screening visit) or surgically sterile by hysterectomy;
7. On stable doses of diuretics, bisphosphonates, anti-epileptics (except dilantin) for at least 2 months.

Exclusion Criteria:

1. Serious underlying systemic disease (including uncontrolled diabetes, lupus, hypertension, amyloid, etc);
2. 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;
3. Taking drugs that the investigator feels will alter calcium balance;
4. Plan to initiate dialysis in the next six months;
5. Hypercalcemia defined as serum calcium \> 10.5 mg/dl;
6. Hyperphosphatemia defined as serum phosphate \>5.5mg/ml;
7. Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, bariatric surgery;
8. Smoking

Primary outcomes:
measure: Calcium Balance
timeFrame: 2 weeks
Secondary outcomes:
measure: Phosphorus Balance
timeFrame: 2 weeks
measure: "Bone Balance" From Calcium Kinetics
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital - Clinical Research Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Munro Peacock, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.