Ignite Creation Date:
2024-05-06 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03348644
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2017-10-09
Brief Title:
Milk Products in the Treatment of Hypophosphatemic Rickets
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Milk Products in the Treatment of Hypophosphatemic Rickets A Randomised Crossover Trial
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to investigate the feasibility and efficacy of a high intake of milk andor cheese products compared to phosphate tablets in patients with hypophosphatemic rickets when evaluating the S-phosphate levels as a main effect parameter The study was designed as a randomized multiple crossover study
Detailed Description:
Objectives
Standard treatment of hypophosphatemic rickets consists of oral phosphate tablets and vitamin D analogous Due to their rapid absorption serum-phosphate fluctuations can occur and secondary hyperparathyroidism may be a consequence Our aim was to evaluate if phosphate supplement administered as milk or cheese is superior or equal to phosphate tablets in patients with hypophosphatemic rickets
Study population
Patients with genetic verified hypophosphatemic rickets were included in the period from August 2015 to June 2016 Patients were excluded from the study if they presented with tertiary hyperparathydoism were treated with Cinacalcet or suffered from milk allergy
Study design
The study was designed as a randomized multiple crossover study with three treatment periods consisting of the regular oral phosphate supplement a high milk intake or a high cheese intake randomizationcom Patients were instructed to discontinue their regular treatment except for their usual doses of D vitamin analogs three days prior to sample collection and instead engage in the study treatment Furthermore they should follow their normal eating habits while undergoing the study treatment which was controlled by food and liquid registrations
At the phosphate supplement session the patients were treated with an 800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose At the cheese session the patients were treated with an estimated phosphate content of 800 mg distributed over 5 meals At the milk session the patients were treated with 800 ml of milk daily corresponding to approximately 800 mg phosphor per day
Sampling
After three days of treatment the patients visited our clinic for anaerobically handled blood samples which were collected 5 times through out one day for calcium phosphate parathyroid hormone fibroblast growth factor 23 and basic phosphatase Urine samples for calcium and phosphate was collected in containers from 0800 to 1200 and from 1200 to 1600 A 24-hour urine samples was obtained from the day before the sampling from 0800 to 0800 hours the following morning
Standard treatment of hypophosphatemic rickets consists of oral phosphate tablets and vitamin D analogous Due to their rapid absorption serum-phosphate fluctuations can occur and secondary hyperparathyroidism may be a consequence Our aim was to evaluate if phosphate supplement administered as milk or cheese is superior or equal to phosphate tablets in patients with hypophosphatemic rickets
Study population
Patients with genetic verified hypophosphatemic rickets were included in the period from August 2015 to June 2016 Patients were excluded from the study if they presented with tertiary hyperparathydoism were treated with Cinacalcet or suffered from milk allergy
Study design
The study was designed as a randomized multiple crossover study with three treatment periods consisting of the regular oral phosphate supplement a high milk intake or a high cheese intake randomizationcom Patients were instructed to discontinue their regular treatment except for their usual doses of D vitamin analogs three days prior to sample collection and instead engage in the study treatment Furthermore they should follow their normal eating habits while undergoing the study treatment which was controlled by food and liquid registrations
At the phosphate supplement session the patients were treated with an 800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose At the cheese session the patients were treated with an estimated phosphate content of 800 mg distributed over 5 meals At the milk session the patients were treated with 800 ml of milk daily corresponding to approximately 800 mg phosphor per day
Sampling
After three days of treatment the patients visited our clinic for anaerobically handled blood samples which were collected 5 times through out one day for calcium phosphate parathyroid hormone fibroblast growth factor 23 and basic phosphatase Urine samples for calcium and phosphate was collected in containers from 0800 to 1200 and from 1200 to 1600 A 24-hour urine samples was obtained from the day before the sampling from 0800 to 0800 hours the following morning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None