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Completed

NCT Number: NCT02095392

Effects of Soluble Phosphate in Humans

The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jena, Thuringia, 07743, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age between 18-60 years
  • physical health

Exclusion criteria

  • postmenopausal women
  • kidney diseases
  • diabetes mellitus
  • metabolic diseases
  • osteoporosis
  • intake of dietary supplements
  • pregnancy and lactation

Treatment and study plan

P1000/Ca0

Dietary Supplement

22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]

P1000/Ca500

Dietary Supplement

22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]

P1000/Ca1000

Dietary Supplement

22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]

Placebo

Dietary Supplement

all participants consume two weeks before intervention the beverage without phosphate and calcium

Primary outcomes

  1. Fasting phosphate concentration in blood

    Time frame: 8 weeks

Secondary outcomes

  1. Calcium and phosphorus metabolism

    Time frame: 8 weeks

    • parameters of phosphate and calcium metabolism (1,25-OHD; 25-OHD;FGF23;PTH)
    • parameters of bone formation and resorption (osteocalcin, P1NP, CTX)
    • minerals in plasma, faeces and urine

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2014
Registry last updated
Dec 2, 2015

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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