NCT02333682

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

October 20, 2014

Last Update Submit

August 5, 2024

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Plasma 25(OH)D concentration at several visits

    6 months

Secondary Outcomes (5)

  • AUC(day1-day183) of 25(OH)D, 1,25(OH)2D, 24,25(OH)2D and vitamin D

    6 months

  • 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

    6 months

  • Time point at which the plasma level of ≥75 nmol/L 25(OH)D is reached (t)

    6 months

  • 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

    6 months

  • Serum calcium and creatinine, albumin, PTH, urine calcium and creatinine and vital signs throughout the study, (Serious) Adverse event assessment and reporting

    6 months

Study Arms (4)

25(OH)D3 (Calcifediol Hy.D) 10 mcg

EXPERIMENTAL

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) 15 mcg

EXPERIMENTAL

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) 20 mcg

EXPERIMENTAL

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

Vitamin D3 (Cholecalciferol) 20 mcg

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3 (Cholecalciferol) 20 mcg

Interventions

25(OH)D3 (Calcifediol Hy.D) 10 mcgDIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D)

25(OH)D3 (Calcifediol Hy.D) 10 mcg
25(OH)D3 (Calcifediol Hy.D) 15 mcgDIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D)

25(OH)D3 (Calcifediol Hy.D) 15 mcg
25(OH)D3 (Calcifediol Hy.D) 20 mcgDIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D)

25(OH)D3 (Calcifediol Hy.D) 20 mcg
Vitamin D3 (Cholecalciferol) 20 mcgDIETARY_SUPPLEMENT

Vitamin D3 (Cholecalciferol)

Vitamin D3 (Cholecalciferol) 20 mcg

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Graeff-Armas LA, Bendik I, Kunz I, Schoop R, Hull S, Beck M. Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults. J Nutr. 2020 Jan 1;150(1):73-81. doi: 10.1093/jn/nxz209.

    PMID: 31518424DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

CalcifediolCholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sarah Hull, MSc

    Leatherhead Food Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

January 7, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 6, 2024

Record last verified: 2024-08