Human Intervention Study With Calcium Phosphate and Vitamin D

NCT ID: NCT01297023

Last Updated: 2012-11-07

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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calcium phosphate vitamin d3 bone metabolism human study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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calcium phosphate

Group Type EXPERIMENTAL

calcium phosphate

Intervention Type DIETARY_SUPPLEMENT

20 subjects consume for 8 weeks a bread enriched with calcium phosphate \[1g calcium/d\]

vitamin d

Group Type EXPERIMENTAL

vitamin d

Intervention Type DIETARY_SUPPLEMENT

20 subjects consume for 8 weeks a bread with vitamin d3 \[10µg/d\]

calcium phosphate and vitamin d

Group Type EXPERIMENTAL

calcium phosphate and vitamin d

Intervention Type DIETARY_SUPPLEMENT

20 subjects consume for 8 weeks a bread enriched with calcium phosphate \[1g calcium/d\] and vitamin d3 (10µg/d\]

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

All participants consume two weeks before intervention a bread without calcium an vitamin d.

Interventions

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calcium phosphate

20 subjects consume for 8 weeks a bread enriched with calcium phosphate \[1g calcium/d\]

Intervention Type DIETARY_SUPPLEMENT

vitamin d

20 subjects consume for 8 weeks a bread with vitamin d3 \[10µg/d\]

Intervention Type 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\]

Intervention Type DIETARY_SUPPLEMENT

placebo

All participants consume two weeks before intervention a bread without calcium an vitamin d.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subjects

Exclusion Criteria

* pregnancy, lactation
* intake of dietary supplements
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jahreis

Prof. Dr. habil

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Jahreis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology

Locations

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Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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Trautvetter U, Neef N, Leiterer M, Kiehntopf M, Kratzsch J, Jahreis G. Effect of calcium phosphate and vitamin D(3) supplementation on bone remodelling and metabolism of calcium, phosphorus, magnesium and iron. Nutr J. 2014 Jan 17;13:6. doi: 10.1186/1475-2891-13-6.

Reference Type DERIVED
PMID: 24438153 (View on PubMed)

Other Identifiers

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LSEP H47-11

Identifier Type: -

Identifier Source: org_study_id