NCT03286673

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

September 11, 2017

Last Update Submit

September 13, 2017

Conditions

Healthy

Keywords

calcium carbonatecalcium phosphatemetabolic effectshuman studycalcium and phosphorus metabolism

Outcome Measures

Primary Outcomes (6)

  • Serum mineral concentration

    Calcium and Phosphate (and others) concentration in serum.

    after 4 weeks of each intervention

  • Stool mineral concentration

    Calcium and Phosphate concentration (and others) in stool from a three day stool collection

    after 4 weeks of each intervention

  • Urine mineral concentration

    Calcium and Phosphate concentration (and others) in urine from a three day urine collection

    after 4 weeks of each intervention

  • Lipids in blood

    Lipids and lipoprotein concentration in serum.

    after 4 weeks of each intervention

  • Sterols

    Neutrals sterols and bile acids in stool from a three day stool collection

    after 4 weeks of each intervention

  • Dietary intake

    Evaluation of the dietary intake using a three day weighed dietary record.

    after 4 weeks of each intervention

Study Arms (4)

calcium phosphate

EXPERIMENTAL

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

Tricalcium Phosphate

EXPERIMENTAL

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

Calcium carbonate

EXPERIMENTAL

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

Placebo

ACTIVE COMPARATOR

Wholemeal and crispy wafer bread without additional calcium additive.

Dietary Supplement: Placebo

Interventions

calcium phosphateDIETARY_SUPPLEMENT
calcium phosphate
Tricalcium PhosphateDIETARY_SUPPLEMENT
Tricalcium Phosphate
Calcium carbonateDIETARY_SUPPLEMENT
Calcium carbonate
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 - 40 years

You may not qualify if:

  • diseases of the gastrointestinal tract
  • pregnancy
  • the intake of any medication (e. g. for thyroid gland)
  • intake of dietary supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

calcium phosphatetricalcium phosphateCalcium Carbonate

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    Friedrich Schiller University Jena, Institute of Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Gerhard Jahreis

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 18, 2017

Study Start

October 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share