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Human Intervention Study With Calcium Phosphate and Vitamin D

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ClinicalTrials.gov Identifier: NCT01297023
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: calcium phosphate Dietary Supplement: vitamin d Dietary Supplement: calcium phosphate and vitamin d Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults
Study Start Date : January 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
Experimental: calcium phosphate Dietary Supplement: calcium phosphate
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]

Experimental: vitamin d Dietary Supplement: vitamin d
20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]

Experimental: calcium phosphate and vitamin 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]

Placebo Comparator: placebo Other: placebo
All participants consume two weeks before intervention a bread without calcium an vitamin d.




Primary Outcome Measures :
  1. bone resorption and bone formation markers in blood and urine [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. concentration of minerals in blood, stool and urine [ Time Frame: 8 weeks ]
  2. blood lipids [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • pregnancy, lactation
  • intake of dietary supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297023


Locations
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Germany
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
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Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gerhard Jahreis, Prof. Dr. habil, University of Jena
ClinicalTrials.gov Identifier: NCT01297023    
Other Study ID Numbers: LSEP H47-11
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Keywords provided by Gerhard Jahreis, University of Jena:
calcium phosphate
vitamin d3
bone metabolism
human study
Additional relevant MeSH terms:
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Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents