Milk Products in the Treatment of Hypophosphatemic Rickets

Not Applicable

Completed

• Conditions: Hypophosphatemic Rickets
• Interventions: Dietary Supplement: High milk intake.; Dietary Supplement: High cheese intake.; Dietary Supplement: Phosphate tablets.

• Registration Number: NCT03348644
• Lead Sponsor: University of Aarhus

Brief Summary

The aim of this study was to investigate the feasibility and efficacy of a high intake of milk and/or 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 (randomization.com). 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 Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-21
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Genetic verified hypophosphatemic rickets.
• In treated with oral phosphate tablets.

Read More

Exclusion Criteria

• Tertiary hyperparathydoism.
• In treatment with Cinacalcet.
• Suffered from milk allergy.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High milk intake.	High milk intake.	800 ml of milk daily corresponding to approximately 800 mg phosphor per day.
High cheese intake.	High cheese intake.	Cheese with an estimated phosphate content of 800 mg distributed over 5 meals.
Phosphate tablets.	Phosphate tablets.	800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose.

Primary Outcome Measures

Name	Time	Method
Serum phosphate.	Three days.	Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.

Secondary Outcome Measures

Name	Time	Method
Fibroblast growth factor 23.	Three days.	Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Parathyroid hormone.	Three days.	Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Total calcium.	Three days.	Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Basic phosphatase.	Three days.	Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Urine phosphate.	One day.	Evaluated in urine samples. Urine samples for 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.
Urine calcium.	One day.	Evaluated in urine samples. Urine samples for calcium 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.

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark