NCT00393289

Brief Summary

The purpose of the study is to determine the uptake of calcium from fish bone meal from salmon and cod in 12 healthy volunteers. A test meal labelled with trace amounts of a radioactive calcium isotope (Ca47) will be given after an overnight fast and whole body retention of calcium will be measured on day 13, 21, and 24 after the test meal day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

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

November 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

October 26, 2006

Last Update Submit

July 19, 2016

Conditions

Calcium Metabolism

Keywords

Calcium absorptionD-vitamin statusWhole body calcium retentionCalcium intakePTH status

Outcome Measures

Primary Outcomes (1)

  • Whole body retention of calcium

Secondary Outcomes (1)

  • D-vitamin and PTH status, serum calcium and phosporus, and calcium intake

Interventions

Calcium controlled dietBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • healthy males
  • BMI: 18-18 kg/m2
  • age: 18-40 years

You may not qualify if:

  • elite athletes
  • on medication
  • gastrointestinal disorders, chronic diseaes
  • smoking
  • prior participation in radioisotpe studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutirtion, The Royal Veterinary and Agricultural University, Denmark

Frederiksberg, Frederiksberg C, 1958, Denmark

Location

Study Officials

  • Susanne Bügel, MSc, PhD

    Institute of Human Nutrition, THe Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

November 1, 2005

Primary Completion

April 1, 2006

Study Completion

March 1, 2007

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

DK(1)