Genetic, Dietary and Environmental Influences on Vitamin D Metabolism

NCT02590614 | Completed

• 1 other identifier: 209517-REV1
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

Determine differences in serum vitamin D metabolism by genetic ancestry.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (4)

• Serum concentrations of 25(OH)D3

  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.

  Three month change

• Serum concentrations of 24,25(OH)2D3

  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.

  Three month change

• Serum concentrations of 1,25(OH)2D3

  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.

  Three month change

• Metabolite Ratio

  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.

  Three months

Study Arms (2)

800 IU Vitamin D

EXPERIMENTAL

Participants will be taking 800 IU/d of vitamin D3 for two months

Dietary Supplement: 800 IU Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo made by Vital Nutrients, Inc. to look exactly like the 800 IU/d caplets by the same company.

Dietary Supplement: Placebo

Interventions

800 IU Vitamin D DIETARY_SUPPLEMENT

Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the intervention group.

Also known as: Vital Nutrients

800 IU Vitamin D

Placebo DIETARY_SUPPLEMENT

Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the placebo group

Also known as: Vital Nutrients Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Clinical Research Center

University Park, Pennsylvania, 16802, United States

Location

Related Publications (65)

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MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Robin T Wilson, PhD

  Penn State Hershey, Department of Public Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health Sciences

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: April 24, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

US (1)