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Genetic, Dietary and Environmental Influences on Vitamin D Metabolism

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ClinicalTrials.gov Identifier: NCT02590614
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Robin Taylor Wilson, Milton S. Hershey Medical Center

Brief Summary:
Determine differences in serum vitamin D metabolism by genetic ancestry.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: 800 IU Vitamin D Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Genetic, Dietary and Environmental Influences on Vitamin D Metabolism
Actual Study Start Date : November 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 800 IU Vitamin D
Participants will be taking 800 IU/d of vitamin D3 for two months
Dietary Supplement: 800 IU Vitamin D
Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the intervention group.
Other Name: Vital Nutrients

Placebo Comparator: Placebo
Placebo made by Vital Nutrients, Inc. to look exactly like the 800 IU/d caplets by the same company.
Dietary Supplement: Placebo
Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the placebo group
Other Name: Vital Nutrients Placebo




Primary Outcome Measures :
  1. Serum concentrations of 25(OH)D3 [ Time Frame: Three month change ]
    Differences in the increase in fasting serum levels of vitamin D metabolite 25(OH)D3 between African American and European American ancestry pairs will be determined at 0, 1 and 2 months.

  2. Serum concentrations of 24,25(OH)2D3 [ Time Frame: Three month change ]
    Differences in the increase in fasting serum levels of vitamin D metabolite 24,25(OH)D3 between African American and European American ancestry pairs will be determined at 0, 1 and 2 months.

  3. Serum concentrations of 1,25(OH)2D3 [ Time Frame: Three month change ]
    Differences in the increase in fasting serum levels of vitamin D metabolite 1,25(OH)D3 between African American and European American ancestry pairs will be determined at 0, 1 and 2 months.

  4. Metabolite Ratio [ Time Frame: Three months ]
    Difference in the upstream to downstream vitamin D metabolite ratios (24,25(OH)2D3 to 25(OH)D3 and 1,25(OH)2D3 to 25(OH)D3) between African American and European American ancestry pairs will be determined at 0, 1 and 2 months.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy African American and Caucasian adult volunteers
  2. Aged 18 to 35
  3. At least 50% African American or at least 50% Caucasian
  4. Willing to take a vitamin D supplement for two months
  5. Willing to attend monthly visits to the clinic for blood draw and vital check
  6. 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.
  7. Willing to avoid tanning bed use during the above mentioned period.
  8. 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.

Exclusion Criteria:

  1. Participants with a fever (100 degrees F or higher) at the time of the visit
  2. 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),
  3. Participants that have received radiation therapy or chemotherapy within the past 4 weeks,
  4. Participants with any of the following on the upper right arm: rashes, a cast, swelling, paralysis, open sores or wounds.
  5. Individuals with blindness and/or deafness
  6. Pregnant participants will be excluded from the study.
  7. Participants taking any of the following medications will be excluded from the study:

    1. Long-term antibiotic use: Clarithromycin, Ciprofloxacin, Erythromycin, Telithromycin, Nafcillin
    2. Chemotherapy for cancer
    3. Prescription vitamin supplement
    4. Anti-convulsants: Carbamazepine, Pentobarbital, Phenobarbital, Phenytoin, Primidone, Fosphenytoin
    5. Erectile dysfunction drugs: sildenafil, vardenafil, tadalafil
    6. Immunosuppressants: Tacrolimus, Cyclosporine A, Sirolimus, Mycophenolate, Glucocorticoids (like Dexamethasone)
    7. Proton-pump inhibitors: omeprazole lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, and esomeprazole
    8. Calcium Channel Blockers: nifedipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine, amlodipine, lacidipine, Verapamil, diltiazem
    9. Diuretics : furosemide, bumetanide, torsemide, ethacrynic acid, amiloride, triamterene, spironolactone, eplerenone,
    10. Statins: lovastatin, simvastatin, atorvastatin, Pravastatin, fluvastatin, rosuvastatin, pitavastatin, Orlistat (Xenical, Alli),
    11. Anti-fungal: Itraconazole, Ketoconazole, Posaconazole, Voriconazole, Fluconazole, Isavuconazole (isavuconazonium sulfate) Clotrimazole
    12. HIV protease inhibitors and other anti-retrovirals : Atazanavir, Boceprevir, Darunavir, Indinavir, Lopinavir, Nelfinavir, Ombitasvirparitaprevirritonavir, Ombitasvirparitaprevirritonavir plus dasabuvir, Ritonavir and ritonavir containing coformulations, Saquinavir, Telaprevir
    13. TB medications: Rifabutin, Rifampin (rifampicin), Rifapentine
    14. 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
    15. As well as CYP3A4 inducers including: Dexamethasone, Enzalutamide, Lumacaftor, Mitotane, St. John's wort, Bexarotene, Bosentan, Dabrafenib, Efavirenz, Eslicarbazepine, Etravirine, Modafinil
    16. Other drugs that will cause a participant to be excluded include: Cholestyramine, Ferric carboxymaltose (treatment of iron deficiency anemia), Dapsone, Metformin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590614


Locations
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United States, Pennsylvania
Penn State Clinical Research Center
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Robin T Wilson, PhD Penn State Hershey, Department of Public Health Sciences
Publications:
Chen TC. Photobiology of Vitamin D. In: Holick MF, ed. Vitamin D: Physiology, Molecular Biology, and Clinical Implications. Towtowa, NJ: Humana Press, Inc.; 1999.
Holick MF. Photobiology of Vitamin D. In: Pike JW, Glorieux FH, eds. Vitamin D. Vol 1. 2nd ed: Elsevier Academic Press; 2005:37-46.

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Responsible Party: Robin Taylor Wilson, Associate Professor of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02590614    
Other Study ID Numbers: 209517-REV1
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents