Effects of Soluble Phosphate in Humans

November 30, 2015 updated by: Prof. Dr. Michael Glei, University of Jena

The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults

The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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 Toxicology

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18-60 years
  • physical health

Exclusion Criteria:

  • postmenopausal women
  • kidney diseases
  • diabetes mellitus
  • metabolic diseases
  • osteoporosis
  • intake of dietary supplements
  • pregnancy and lactation

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: P1000/Ca0
22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]
Dietary supplement: P1000/Ca500
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]
Dietary supplement: P1000/Ca1000
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]
Experimental: P1000/Ca0
Dietary supplement: P1000/Ca0
22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]
Dietary supplement: Placebo
all participants consume two weeks before intervention the beverage without phosphate and calcium
Experimental: P1000/Ca500
Dietary supplement: Placebo
all participants consume two weeks before intervention the beverage without phosphate and calcium
Dietary supplement: P1000/Ca500
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]
Experimental: P1000/Ca1000
Dietary supplement: Placebo
all participants consume two weeks before intervention the beverage without phosphate and calcium
Dietary supplement: P1000/Ca1000
22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting phosphate concentration in blood
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium and phosphorus metabolism
Time Frame: 8 weeks
  • parameters of phosphate and calcium metabolism (1,25-OHD; 25-OHD;FGF23;PTH)
  • parameters of bone formation and resorption (osteocalcin, P1NP, CTX)
  • minerals in plasma, faeces and urine
8 weeks

Collaborators and Investigators

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

Sponsor

University of Jena

Investigators

  • Principal Investigator: Michael Glei, Prof. Dr., Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology

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

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H55-14

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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