Human Intervention Study With Calcium Phosphate and Vitamin D

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01297023
First received: February 15, 2011
Last updated: November 6, 2012
Last verified: November 2012

February 15, 2011
November 6, 2012
January 2011
April 2011   (final data collection date for primary outcome measure)
bone resorption and bone formation markers in blood and urine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01297023 on ClinicalTrials.gov Archive Site
  • concentration of minerals in blood, stool and urine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • blood lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Subjects
  • Dietary Supplement: calcium phosphate
    20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]
  • Dietary Supplement: vitamin d
    20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]
  • Dietary Supplement: calcium phosphate and vitamin d
    20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]
  • Other: placebo
    All participants consume two weeks before intervention a bread without calcium an vitamin d.
  • Experimental: calcium phosphate
    Intervention: Dietary Supplement: calcium phosphate
  • Experimental: vitamin d
    Intervention: Dietary Supplement: vitamin d
  • Experimental: calcium phosphate and vitamin d
    Intervention: Dietary Supplement: calcium phosphate and vitamin d
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Trautvetter U, Neef N, Leiterer M, Kiehntopf M, Kratzsch J, Jahreis G. Effect of calcium phosphate and vitamin D₃ 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • pregnancy, lactation
  • intake of dietary supplements
Both
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01297023
LSEP H47-11
Yes
Gerhard Jahreis, University of Jena
University of Jena
Not Provided
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
University of Jena
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP