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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
History of Changes
  Purpose

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 Intervention
Healthy Subjects
 Dietary Supplement: calcium phosphate
Dietary Supplement: vitamin d
Dietary Supplement: calcium phosphate and vitamin d
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • bone resorption and bone formation markers in blood and urine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • pregnancy, lactation
  • intake of dietary supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297023

Locations
Germany
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr. habil, University of Jena
ClinicalTrials.gov Identifier: NCT01297023     History of Changes
Other Study ID Numbers: LSEP H47-11
Study First Received: February 15, 2011
Last Updated: November 6, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
calcium phosphate
vitamin d3
bone metabolism
human study

Additional relevant MeSH terms:
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013