Human Intervention Study With Calcium Phosphate and Vitamin D

Healthy Subjects Clinical Trial

Official title:

The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297023
• Other study ID #: LSEP H47-11
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: November 6, 2012
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy subjects

Exclusion Criteria:

• pregnancy, lactation

• intake of dietary supplements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• calcium phosphate
20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]
• vitamin d
20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]
• 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.

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone resorption and bone formation markers in blood and urine		8 weeks	Yes
Secondary	concentration of minerals in blood, stool and urine		8 weeks	Yes
Secondary	blood lipids		8 weeks	No