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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03425747 |
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Date of registration:
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27/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism
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Scientific title:
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CALCIUM CITRATE vs CALCIUM CARBONATE FOR THE MANAGEMENT OF CHRONIC HYPOPARATHYROIDISM |
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Date of first enrolment:
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October 15, 2019 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03425747 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hypoparathyroidism
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Intervention(s)
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Drug: Calcium Carbonate
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Drug: Calcium Citrate
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Primary Outcome(s)
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Change in calcium oxalate saturation
[Time Frame: 0, 1 and 2 months]
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Change in serum calcium level
[Time Frame: 0, 1 and 2 months]
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Secondary Outcome(s)
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Change in Quality of life and fatigue
[Time Frame: 0,1,2 months]
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Secondary ID(s)
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Ca Citrate VS Ca Carbonate
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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