Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of Calcifediol and Cholecalciferol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333682
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
Leatherhead Food Research
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Brief Summary:
The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 10 mcg Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 15 mcg Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 20 mcg Dietary Supplement: Vitamin D3 (Cholecalciferol) 20 mcg Not Applicable

Detailed Description:
Reaching consistent levels of 25(OH)D has been shown to be crucial in decreasing falls, fractures and increasing calcium absorption. One way to circumvent the variability of 25(OH)D response to vitamin D might be to use calcifediol supplementation and bypass the 25-hydroxylase enzyme entirely. This approach also permits the physician to achieve desired serum levels in a matter of just a few days, rather than the several weeks required when using native vitamin D. Compared to native vitamin D, calcifediol is more water soluble, has a shorter half-life and increases 25(OH)D levels more quickly. Calcifediol is also more potent, about 3.5 times more potent in raising 25(OH)D levels than vitamin D. Its water solubility may also confer an advantage in patients who have difficulty absorbing fat soluble vitamins. This form of vitamin D metabolite has been used historically to increase calcium absorption, treat osteomalacia, and increase Bone Mineral Density (BMD). Using calcifediol seems to be a practical solution, but little is known about the dose response variability in humans and how it compares to that of native vitamin D. The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Response of Serum 25-hydroxyvitamin D to Different Doses of Calcifediol Hy.D Compared to Vitamin D3 Supplementation: A Randomized, Controlled, Double Blind, Long Term Pharmacokinetic Study
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: 25(OH)D3 (Calcifediol Hy.D) 10 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 10 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 10 mcg
25(OH)D3 (Calcifediol Hy.D)

Experimental: 25(OH)D3 (Calcifediol Hy.D) 15 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 15 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 15 mcg
25(OH)D3 (Calcifediol Hy.D)

Experimental: 25(OH)D3 (Calcifediol Hy.D) 20 mcg
25(OH)D3 (Calcifediol Hy.D), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary Supplement: 25(OH)D3 (Calcifediol Hy.D) 20 mcg
25(OH)D3 (Calcifediol Hy.D)

Active Comparator: Vitamin D3 (Cholecalciferol) 20 mcg
Vitamin D3 (Cholecalciferol), Dose: 20 mcg, 1 capsule/day before breakfast, Duration: 6 months
Dietary Supplement: Vitamin D3 (Cholecalciferol) 20 mcg
Vitamin D3 (Cholecalciferol)




Primary Outcome Measures :
  1. Plasma 25(OH)D concentration at several visits [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. AUC(day1-day183) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D [ Time Frame: 6 months ]
  2. AUC(day1), Cmax(day1), Tmax(day1) and AUC(day182), Cmax(day182), Tmax(day182) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D [ Time Frame: 6 months ]
  3. Time point at which the plasma level of ≥75 nmol/L 25(OH)D is reached (t) [ Time Frame: 6 months ]
  4. Elimination rate and half-life of of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D after cessation of supplementation [ Time Frame: 6 months ]
  5. Serum calcium and creatinine, albumin, PTH, urine calcium and creatinine and vital signs throughout the study, (Serious) Adverse event assessment and reporting [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males >50 years in age
  • Healthy postmenopausal women >50 years in age, who have not experienced a menstrual bleeding for a minimum of 12 months
  • BMI between 20-32 kg/m2
  • Subject understands the study procedures and signs the informed consent to participate in the study
  • Subject has clear understanding of the English language
  • Caucasian ethnicity
  • Willingness to avoid direct sun exposure and to restrict travel to sunny climates during the whole study period.

Exclusion Criteria:

  • Subject has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator
  • Subjects with a history of hypercalcemia (Serum calcium adjusted for albumin of > 2.6 nmol/l)
  • Supplemental calcium intake beyond 500 mg per day during the entire study and follow up
  • Any vitamin D supplementation within 2 months before the baseline blood draw and during the entire study and follow up
  • Subject has gastrointestinal malabsorption (from coeliac disease, colitis, surgery etc.)
  • Subject has kidney disease or liver disease
  • Medication: Bisphosphonate or Parathyroid Hormone (PTH) treatment, use of steroids in any form, anticonvulsants, antibiotics, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali).
  • Use of Hormone Replacement Therapy (HRT) within the previous 6 months
  • Subject has signs of acute or severe illness (i.e. unintentional weight loss, night sweats etc.)
  • Subject has a known allergy or sensitivity to the investigational products or any ingredients of the investigational products
  • Subject heavily consumes alcohol containing products defined as greater than (>) 3 drinks for men or 2 drinks for women (1 drink is 11 grams of alcohol or equivalence of 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) of alcoholic beverages per day
  • Subject has donated more than 300 mL of blood during the last three months prior to screening
  • Participating in another clinical trial
  • Women who are premenopausal
  • Subjects with active current psychiatric illness or condition which is likely to interfere with the subject's ability to understand the requirements of the biomedical research project
  • Sunbed users will be excluded from the study.
  • (Expected) increase in exposure to sunlight (e.g. a planned holiday of more than eight days, a beach holiday or a holiday outside Europe) in the study period of day 01 until day 28.

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): NCT02333682


Sponsors and Collaborators
DSM Nutritional Products, Inc.
Leatherhead Food Research
Investigators
Layout table for investigator information
Principal Investigator: Sarah Hull, MSc Leatherhead Food Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02333682    
Other Study ID Numbers: 2013-04-17-HDPK
127927 ( Other Identifier: Leatherhead Food Research )
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents