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Milk Products in the Treatment of Hypophosphatemic Rickets

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ClinicalTrials.gov Identifier: NCT03348644
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborators:
University of East Anglia
Kolding Sygehus
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypophosphatemic Rickets Dietary Supplement: Phosphate tablets. Dietary Supplement: High cheese intake. Dietary Supplement: High milk intake. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, multiple crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Milk Products in the Treatment of Hypophosphatemic Rickets: A Randomised Crossover Trial
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348644


Locations
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Denmark
Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
University of East Anglia
Kolding Sygehus
Aarhus University Hospital
Investigators
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Principal Investigator: Niels Birkebæk., MD, PhD Aarhus University Hospital

Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03348644     History of Changes
Other Study ID Numbers: Milk products in HPR
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia
Phosphorus Metabolism Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn