Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00742820
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent form
* Ages: 18-75 years
* Serum Calcium level 8.6-10.2 mg/dL
* 25 vitamin D level 20-100 ng/mL
* 1, 25 dihydroxy vitamin D level 6-62 pg/mL
* Fasting glucose level of 65-99 mg/dL (min 8 hr fast)
* iPTH level of 10-65 pg/mL
* Serum phosphorous level of 2.5-4.5 mg/dL
* Albumin level of 3.6-5.1 g/dL
* Sodium level of 135-146 mEq/L
* Potassium level of 3.5-5.3 mEq/L
* Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study
* No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR
* No clinically significant abnormalities on liver function tests
* No clinically significant abnormalities on CBC and coagulation studies
* No clinically significant abnormalities on kidney function (eGFR using serum creatinine)
* BMI between 18.5-30
* Subjects must agree not to consume alcohol while in the treatment phase of the study
Exclusion Criteria:
* Women who are pregnant or breast feeding
* Malignancy except squamous cell carcinoma of the skin
* Documented current acute or chronic disease
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Myocardial infarction within 6 months of study Day 0
* Parathyroidectomy within 6 months of study Day 0
* Gastrointestinal disorder associated with impaired absorption of oral medications
* Inability to swallow tablets or tolerate calcium acetate oral solution
* Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy
* Concurrent antibiotic treatment
* Any concurrent investigational treatment within 30 days of screening
* Unable or unwilling to comply fully with the protocol
* Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening
* Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements
* Subjects testing positive for drugs of abuse
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00742820
Study Brief:
Protocol Section:
NCT00742820