Healthy Combine Study

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration: 12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives: Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria: Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration of administration: 2 weeks (length of time study participants are enrolled in study) Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis using mixed linear models

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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