Comparison of Three Calcium Supplements

September 13, 2017 updated by: Gerhard Jahreis, University of Jena

Comparison of Three Calcium Supplements With Regard to Their Metabolic Effects in Healthy Adults

The study was conducted to investigate the metabolic effects of three different calcium compounds in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 - 40 years

Exclusion Criteria:

  • diseases of the gastrointestinal tract
  • pregnancy
  • the intake of any medication (e. g. for thyroid gland)
  • 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: calcium phosphate
Pentacalcium hydroxy-triphosphate (Ca5(PO4)3OH) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
Dietary supplement: calcium phosphate
EXPERIMENTAL: Tricalcium Phosphate
β-tricalcium phosphate (Ca3(PO4)2) as incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
Dietary supplement: Tricalcium Phosphate
EXPERIMENTAL: Calcium carbonate
Calcium carbonate (CaCO3) was incorporated in wholemeal and crispy wafer bread in order to achieve a additional calcium intake of 1000 mg/d.
Dietary supplement: Calcium carbonate
ACTIVE_COMPARATOR: Placebo
Wholemeal and crispy wafer bread without additional calcium additive.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum mineral concentration
Time Frame: after 4 weeks of each intervention
Calcium and Phosphate (and others) concentration in serum.
after 4 weeks of each intervention
Stool mineral concentration
Time Frame: after 4 weeks of each intervention
Calcium and Phosphate concentration (and others) in stool from a three day stool collection
after 4 weeks of each intervention
Urine mineral concentration
Time Frame: after 4 weeks of each intervention
Calcium and Phosphate concentration (and others) in urine from a three day urine collection
after 4 weeks of each intervention
Lipids in blood
Time Frame: after 4 weeks of each intervention
Lipids and lipoprotein concentration in serum.
after 4 weeks of each intervention
Sterols
Time Frame: after 4 weeks of each intervention
Neutrals sterols and bile acids in stool from a three day stool collection
after 4 weeks of each intervention
Dietary intake
Time Frame: after 4 weeks of each intervention
Evaluation of the dietary intake using a three day weighed dietary record.
after 4 weeks of each intervention

Collaborators and Investigators

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

Sponsor

University of Jena

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., Friedrich Schiller University Jena, Institute of Nutrition

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 (ACTUAL)

October 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H28-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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