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Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism

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ClinicalTrials.gov Identifier: NCT03425747
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Palermo, Campus Bio-Medico University

Brief Summary:
Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of hypocalcaemia, maintain serum calcium levels in the low normal range and improve the patient's QoL Calcium carbonate is most often used and less expensive than other calcium preparations and contains the highest concentration of elemental calcium per gram (42%). It requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients it is better to find an alternative to calcium carbonate. Calcium citrate should be recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI) as well as to patients who preferred to take supplements outside mealtimes. furthermore, patients with hypoparathyroidism have an increased risk of kidney stones. Kidney stones are formed by calcium salts, among which the most frequent ones are calcium-oxalate (70-80%), followed by calcium-phosphate and uric acid. Citrate salts are widely used in the treatmentof nephrolithiasis, since have shown an inhibitory effect on kidney stone formation. Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the management of subjects with chronic hypoparathyroidism. In particular, we will investigate if calcium citrate compared to calcium carbonate does not affect the risk of renal stones, if it is able to maintain normal calcium levels and, if it has an impact on QOL, in subjects with chronic hypoparathyroidism.

Condition or disease Intervention/treatment Phase
Chronic Hypoparathyroidism Drug: Calcium Carbonate Drug: Calcium Citrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISM
Actual Study Start Date : October 15, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020


Arm Intervention/treatment
Active Comparator: Calcium Carbonate
Calcium Carbonate
Drug: Calcium Carbonate
subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.

Drug: Calcium Citrate
subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.

Active Comparator: calcium Citrate
Calcium Citrate
Drug: Calcium Carbonate
subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.

Drug: Calcium Citrate
subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.




Primary Outcome Measures :
  1. Change in serum calcium level [ Time Frame: 0, 1 and 2 months ]
    albumin-adjusted calcium levels

  2. Change in calcium oxalate saturation [ Time Frame: 0, 1 and 2 months ]
    24-h urinary calcium oxalate saturation


Secondary Outcome Measures :
  1. Change in Quality of life and fatigue [ Time Frame: 0,1,2 months ]
    PCS and MCS (by SF-36 survey) and fatigue score



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of postsurgical chronic hypoparathyroidism by at least 6 months
  • No change of treatment over the last 3 months prior to enrollment.
  • Values of serum calcium and phosphorus stable over the last three months prior to enrollment
  • Absence of symptoms from hypocalcaemia in the 3 months prior to enrollment
  • A requirement for active vitamin D (calcitriol ≥0.25 mcg daily) and oral calcium (≥1000 mg daily) treatment.

Exclusion Criteria:

  • liver failure
  • renal failure (gfr <30 ml/min)
  • hypercalcemia
  • hyperthyroidism
  • parathyroid disorders
  • use of the following drugs within 3 months of the study: diuretics, bisphosphonates, calcitonin, corticosteroids, anabolic steroids, anticonvulsants, H2 receptor antagonists or proton pump inhibitor
  • heavy smokers (>10 cigarettes/day)
  • abusing alcohol (>70 ml/day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425747


Locations
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Italy
Campus Bio-Medico University
Roma, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Publications:

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Responsible Party: Andrea Palermo, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT03425747    
Other Study ID Numbers: Ca Citrate VS Ca Carbonate
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Palermo, Campus Bio-Medico University:
calcium carbonate
calcium citrate
quality of life
hypoparathyroidism
hypocalcemia
calicum oxalate saturation
kydney stone
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Calcium, Dietary
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Antacids
Gastrointestinal Agents