Milk Products in the Treatment of Hypophosphatemic Rickets

November 15, 2017 updated by: University of Aarhus

Milk Products in the Treatment of Hypophosphatemic Rickets: A Randomised Crossover Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum phosphate.
Time Frame: Three days.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Three days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast growth factor 23.
Time Frame: Three days.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Three days.
Parathyroid hormone.
Time Frame: Three days.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Three days.
Total calcium.
Time Frame: Three days.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Three days.
Basic phosphatase.
Time Frame: Three days.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Three days.
Urine phosphate.
Time Frame: 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.
One day.
Urine calcium.
Time Frame: 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.
One day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
University of East Anglia
Kolding Sygehus

Investigators

  • Principal Investigator: Niels Birkebæk., MD, PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Milk products in HPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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