N/A
N=12
Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01161407 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Calcium Balance — 61; 508 mg/d calcium
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1500 mg/d elemental calcium as calcium carbonate (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calcium Balance |
61; 508 | — |
| SECONDARY Phosphorus Balance |
95; 153 | — |
| SECONDARY "Bone Balance" From Calcium Kinetics |
62; 259 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a GFR of 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01161407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.