Status:
COMPLETED
A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism Patients
Lead Sponsor:
Amorphical Ltd.
Conditions:
Hypoparathyroidism
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/d...
Detailed Description
Eligible subjects will be treated as follows: Phase I Ten (10) subjects previously diagnosed and chronically treated for primary hypoparathyroidism will be enrolled. The daily CCS intake will be grad...
Eligibility Criteria
Inclusion
- Primary Hypoparathyroidism - low levels of intact PTH during hypocalcemia at diagnosis.
- Subjects receiving calcium and vitamin D supplementation at least 1 year prior to the beginning of the study.
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects who provide written informed consent to participate in the study.
- Age: 18-80, inclusive.
Exclusion
- Calcium (albumin corrected) serum values below 7.0 mg/dL or above 10.0 mg/dL
- Any known diseases affecting the absorption from the gastrointestinal tract:
- Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- Chronic diarrhea
- Subjects with neuropsychiatric disease.
- Subjects with impaired renal function (glomerular filtration rate, ≤40 mL/min)
- Subjects with other severe chronic disease requiring long-term therapy.
- Impaired liver function (Liver enzymes\> x3 upper limit of normal).
- Subjects with history or presence of kidney stones
- Recurrent urinary tract infections
- Subjects taking drugs which might affect calcium levels such as:
- Fusid
- Anticonvulsants
- Carbonic anhydrase
- Adrenocorticosteroids
- Subjects who are non-cooperative or unwilling to sign consent form.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01815021
Start Date
April 1 2013
End Date
June 1 2014
Last Update
March 31 2015
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel, 31096