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N/A Completed N=12 Randomized Quadruple-blind Treatment

Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease

Source: ClinicalTrials.gov NCT01161407 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Calcium Balance — 61; 508 mg/d calcium

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Calcium Balance
61; 508
SECONDARY
Phosphorus Balance
95; 153
SECONDARY
"Bone Balance" From Calcium Kinetics
62; 259

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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