MedDataX Logo

Safety and Bioefficacy of Vitamin D2 and Vitamin D3

NCT ID: NCT01503216

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.

Groups/Cohorts Assigned Interventions

1. Placebo group
2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

randomized controlled trial vitamin D bioavailability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cholecalciferol

Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks

Group Type EXPERIMENTAL

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol, 2000 IU per day, 8 weeks

Ergocalciferol

Ergocalciferol 2000 IU per day for 8 weeks

Group Type EXPERIMENTAL

ergocalciferol

Intervention Type DIETARY_SUPPLEMENT

vitamin d2, 2000 IU per day for 8 weeks

Placebo

Placebo for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cholecalciferol

cholecalciferol, 2000 IU per day, 8 weeks

Intervention Type DIETARY_SUPPLEMENT

ergocalciferol

vitamin d2, 2000 IU per day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cholecalciferol, vitamin D3

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years
* healthy

Exclusion Criteria

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ulrike Lehmann

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ulrike Lehmann

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jutta Dierkes, Prof. Dr.

Role: STUDY_DIRECTOR

Institut für Agrar- und Ernährungswissenschaften

References

Explore related publications, articles, or registry entries linked to this study.

Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.

Reference Type DERIVED
PMID: 24001747 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMBF 0315668A

Identifier Type: -

Identifier Source: org_study_id