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Completed

NCT Number: NCT01297023

Human Intervention Study With Calcium Phosphate and Vitamin D

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.

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Key information

Conditions

Healthy Subjects

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects

Exclusion criteria

  • pregnancy, lactation
  • intake of dietary supplements

Treatment and study plan

calcium phosphate

Dietary Supplement

20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]

Vitamin D

Dietary Supplement

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

calcium phosphate and vitamin d

Dietary Supplement

20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]

Placebo

Other

All participants consume two weeks before intervention a bread without calcium an vitamin d.

Primary outcomes

  1. bone resorption and bone formation markers in blood and urine

    Time frame: 8 weeks

Secondary outcomes

  1. concentration of minerals in blood, stool and urine

    Time frame: 8 weeks

  2. blood lipids

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 16, 2011
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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