Human Intervention Study With Calcium Phosphate and Vitamin D
The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 7, 2012
November 1, 2012
3 months
February 15, 2011
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone resorption and bone formation markers in blood and urine
8 weeks
Secondary Outcomes (2)
concentration of minerals in blood, stool and urine
8 weeks
blood lipids
8 weeks
Study Arms (4)
calcium phosphate
EXPERIMENTALvitamin d
EXPERIMENTALcalcium phosphate and vitamin d
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
20 subjects consume for 8 weeks a bread enriched with calcium phosphate \[1g calcium/d\]
20 subjects consume for 8 weeks a bread with vitamin d3 \[10µg/d\]
20 subjects consume for 8 weeks a bread enriched with calcium phosphate \[1g calcium/d\] and vitamin d3 (10µg/d\]
All participants consume two weeks before intervention a bread without calcium an vitamin d.
Eligibility Criteria
You may qualify if:
- healthy subjects
You may not qualify if:
- pregnancy, lactation
- intake of dietary supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, 07743, Germany
Related Publications (1)
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.
PMID: 24438153DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Jahreis, Prof. Dr.
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. habil
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 16, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
November 7, 2012
Record last verified: 2012-11