Human Intervention Study With Calcium Phosphate and Vitamin D

November 6, 2012 updated by: Gerhard Jahreis, University of Jena

The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults

The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • pregnancy, lactation
  • intake of dietary supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
All participants consume two weeks before intervention a bread without calcium an vitamin d.
Experimental: vitamin d
Dietary supplement: vitamin d
20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]
Experimental: calcium phosphate
Dietary supplement: calcium phosphate
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]
Experimental: calcium phosphate and vitamin d
Dietary supplement: calcium phosphate and vitamin d
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone resorption and bone formation markers in blood and urine
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
concentration of minerals in blood, stool and urine
Time Frame: 8 weeks
8 weeks
blood lipids
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP H47-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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