Effects of Soluble Phosphate in Humans

University of Jena

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: P1000/Ca500; Dietary Supplement: Placebo; Dietary Supplement: P1000/Ca0; Dietary Supplement: P1000/Ca1000

Study type: Interventional

Funder types: Other

Identifiers

NCT02095392

H55-14

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 4 patient groups, including a placebo group

P1000/Ca0

Experimental group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: P1000/Ca0

P1000/Ca500

Experimental group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: P1000/Ca500

P1000/Ca1000

Experimental group

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: P1000/Ca1000

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: P1000/Ca0

Dietary Supplement: P1000/Ca1000

Dietary Supplement: P1000/Ca500