Effects of Soluble Phosphate in Humans

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: P1000/Ca0; Dietary Supplement: P1000/Ca1000; Dietary Supplement: P1000/Ca500; Dietary Supplement: Placebo

• Registration Number: NCT02095392
• Lead Sponsor: University of Jena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P1000/Ca0	P1000/Ca0	-
P1000/Ca1000	P1000/Ca1000	-
Placebo	P1000/Ca500	-
Placebo	P1000/Ca1000	-
P1000/Ca0	Placebo	-
P1000/Ca500	P1000/Ca500	-
P1000/Ca500	Placebo	-
Placebo	P1000/Ca0	-
P1000/Ca1000	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fasting phosphate concentration in blood	8 weeks

Secondary Outcome Measures

Name	Time	Method
Calcium and phosphorus metabolism	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

Trial Locations

Locations (1)

Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology; 🇩🇪 Jena, Thuringia, Germany