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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03136705
Eligibility Criteria:
INCLUSION CRITERIA
Healthy volunteers
Age ≥ 18 years, at the time of screening
Normal renal function at screening, as defined by
* eGFR \> 60
* no albuminuria
* normal urinalysis
* normotensive, defined as blood pressure \<140/85mmHg
* no known history of CKD
Adequate organ and marrow function at screening as defined below:
* HCT ≥ 30%
* platelets ≥ 125,000/mm3
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit
* 25-hydroxyvitamin D ≥ 10mg/dL
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Ability to understand and the willingness to sign a written informed consent.
EXCLUSION CRITERIA:
History of allergic reaction to nicotinamide, niacin (excluding flushing), and/or multivitamin preparations
Liver disease, defined as known cirrhosis by imaging or physician diagnosis.
* Documented alcohol use \> 14 drinks/week
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase concentrations \> 2 times the upper limit of the local laboratory reference range and/or total bilirubin concentration not within institutional limits.
Creatine kinase (CK) concentrations \> 2 times the upper limit of the local laboratory reference range at screening
Major hemorrhagic event within the past six months from screening requiring inpatient admission.
Blood or platelet transfusion within the past six months from screening
History of primary hyperparathyroidism
Current, clinically significant malabsorption
Anemia (screening HCT \< 30%) at screening
Plasma albumin \< 2.5 mg/dl at screening
25-hydroxyvitamin D \<10mg/dL at screening
Inability or unwillingness to provide consent
Current or recent treatment (within the last 14 days from screening) with niacin/nicotinamide \> 100 mg/day
Current or recent use of MVI containing niacin/nicotinamide \> 100 mg/day
Current use of Tums (or calcium carbonate taken for indigestion) at a dose of \>1000 mg daily
Current participation in another clinical trial or other interventional research
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03136705
Study Brief:
Protocol Section:
NCT03136705