Genetic, Dietary and Environmental Influences on Vitamin D Metabolism

Completed · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency

In brief

Determine differences in serum vitamin D metabolism by genetic ancestry.

Key facts

Study ID

NCT02590614

Run by

Milton S. Hershey Medical Center

People needed

412

Starts

2013-11-01

Expected to finish

2019-04-24

Last updated by the study team

2019-05-08

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy African American and Caucasian adult volunteers
• Aged 18 to 35
• At least 50% African American or at least 50% Caucasian
• Willing to take a vitamin D supplement for two months
• Willing to attend monthly visits to the clinic for blood draw and vital check
• Willing to refrain from taking other dietary supplements including herbal supplements, multi-vitamins and vitamin D supplements other than the supplements provided in the trial.
• Willing to avoid tanning bed use during the above mentioned period.
• Willing to avoid extensive use of analgesics and have the consumption of the following drugs recorded: Acetaminophen, Celecoxib, Codeine, Fentanyl, any antibiotics, and Hormonal IUD.

You may not qualify if…

• Participants with a fever (100 degrees F or higher) at the time of the visit
• Participants with severe chronic disease (i.e., chronic kidney disease, cirrhosis of the liver, heart attack, HIV/AIDS, alcoholism, hemophilia, sickle cell disease, or other serious underlying illness that prevents blood donation),
• Participants that have received radiation therapy or chemotherapy within the past 4 weeks,
• Participants with any of the following on the upper right arm: rashes, a cast, swelling, paralysis, open sores or wounds.
• Individuals with blindness and/or deafness
• Pregnant participants will be excluded from the study.
• Participants taking any of the following medications will be excluded from the study:
• Long-term antibiotic use: Clarithromycin, Ciprofloxacin, Erythromycin, Telithromycin, Nafcillin
• Chemotherapy for cancer
• Prescription vitamin supplement
• Anti-convulsants: Carbamazepine, Pentobarbital, Phenobarbital, Phenytoin, Primidone, Fosphenytoin
• Erectile dysfunction drugs: sildenafil, vardenafil, tadalafil
• Immunosuppressants: Tacrolimus, Cyclosporine A, Sirolimus, Mycophenolate, Glucocorticoids (like Dexamethasone)
• Proton-pump inhibitors: omeprazole lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, and esomeprazole
• Calcium Channel Blockers: nifedipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, amlodipine, lacidipine, Verapamil, diltiazem
• Diuretics : furosemide, bumetanide, torsemide, ethacrynic acid, amiloride, triamterene, spironolactone, eplerenone,
• Statins: lovastatin, simvastatin, atorvastatin, Pravastatin, fluvastatin, rosuvastatin, pitavastatin, Orlistat (Xenical, Alli),
• Anti-fungal: Itraconazole, Ketoconazole, Posaconazole, Voriconazole, Fluconazole, Isavuconazole (isavuconazonium sulfate) Clotrimazole
• HIV protease inhibitors and other anti-retrovirals : Atazanavir, Boceprevir, Darunavir, Indinavir, Lopinavir, Nelfinavir, Ombitasvirparitaprevirritonavir, Ombitasvirparitaprevirritonavir plus dasabuvir, Ritonavir and ritonavir containing coformulations, Saquinavir, Telaprevir
• TB medications: Rifabutin, Rifampin (rifampicin), Rifapentine
• As well as CYP3A4 inhibitors including: Ceritinib, Cobicistat and cobicistat containing coformulations, Idelalisib, Nefazodone, Amiodarone, Aprepitant, Cimetidine, Conivaptan, Crizotinib, Delavirdine, Desipramine, Dronedarone, Fosaprepitant Mifepristone, Netupitant, Nilotinib, and Tibolone
• As well as CYP3A4 inducers including: Dexamethasone, Enzalutamide, Lumacaftor, Mitotane, St. John's wort, Bexarotene, Bosentan, Dabrafenib, Efavirenz, Eslicarbazepine, Etravirine, Modafinil
• Other drugs that will cause a participant to be excluded include: Cholestyramine, Ferric carboxymaltose (treatment of iron deficiency anemia), Dapsone, Metformin

Where it is running

• Penn State Clinical Research Center — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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