NCT03348644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
Last Updated

November 21, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 9, 2017

Last Update Submit

November 15, 2017

Conditions

Hypophosphatemic Rickets

Outcome Measures

Primary Outcomes (1)

  • Serum phosphate.

    Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.

    Three days.

Secondary Outcomes (6)

  • Fibroblast growth factor 23.

    Three days.

  • Parathyroid hormone.

    Three days.

  • Total calcium.

    Three days.

  • Basic phosphatase.

    Three days.

  • Urine phosphate.

    One day.

  • +1 more secondary outcomes

Study Arms (3)

Phosphate tablets.

EXPERIMENTAL

800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose.

Dietary Supplement: Phosphate tablets.

High cheese intake.

ACTIVE COMPARATOR

Cheese with an estimated phosphate content of 800 mg distributed over 5 meals.

Dietary Supplement: High cheese intake.

High milk intake.

ACTIVE COMPARATOR

800 ml of milk daily corresponding to approximately 800 mg phosphor per day.

Dietary Supplement: High milk intake.

Interventions

Phosphate tablets.DIETARY_SUPPLEMENT
Phosphate tablets.
High cheese intake.DIETARY_SUPPLEMENT
High cheese intake.
High milk intake.DIETARY_SUPPLEMENT
High milk intake.

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (10)

  • Beck-Nielsen SS, Brock-Jacobsen B, Gram J, Brixen K, Jensen TK. Incidence and prevalence of nutritional and hereditary rickets in southern Denmark. Eur J Endocrinol. 2009 Mar;160(3):491-7. doi: 10.1530/EJE-08-0818. Epub 2008 Dec 18.

    PMID: 19095780BACKGROUND

  • Beck-Nielsen SS, Brixen K, Gram J, Brusgaard K. Mutational analysis of PHEX, FGF23, DMP1, SLC34A3 and CLCN5 in patients with hypophosphatemic rickets. J Hum Genet. 2012 Jul;57(7):453-8. doi: 10.1038/jhg.2012.56. Epub 2012 Jun 14.

    PMID: 22695891BACKGROUND

  • Minisola S, Peacock M, Fukumoto S, Cipriani C, Pepe J, Tella SH, Collins MT. Tumour-induced osteomalacia. Nat Rev Dis Primers. 2017 Jul 13;3:17044. doi: 10.1038/nrdp.2017.44.

    PMID: 28703220BACKGROUND

  • Bastepe M, Juppner H. Inherited hypophosphatemic disorders in children and the evolving mechanisms of phosphate regulation. Rev Endocr Metab Disord. 2008 Jun;9(2):171-80. doi: 10.1007/s11154-008-9075-3. Epub 2008 Mar 26.

    PMID: 18365315BACKGROUND

  • Carpenter TO, Imel EA, Holm IA, Jan de Beur SM, Insogna KL. A clinician's guide to X-linked hypophosphatemia. J Bone Miner Res. 2011 Jul;26(7):1381-8. doi: 10.1002/jbmr.340. Epub 2011 May 2.

    PMID: 21538511BACKGROUND

  • Saito H, Kusano K, Kinosaki M, Ito H, Hirata M, Segawa H, Miyamoto K, Fukushima N. Human fibroblast growth factor-23 mutants suppress Na+-dependent phosphate co-transport activity and 1alpha,25-dihydroxyvitamin D3 production. J Biol Chem. 2003 Jan 24;278(4):2206-11. doi: 10.1074/jbc.M207872200. Epub 2002 Nov 4.

    PMID: 12419819BACKGROUND

  • Bergwitz C, Roslin NM, Tieder M, Loredo-Osti JC, Bastepe M, Abu-Zahra H, Frappier D, Burkett K, Carpenter TO, Anderson D, Garabedian M, Sermet I, Fujiwara TM, Morgan K, Tenenhouse HS, Juppner H. SLC34A3 mutations in patients with hereditary hypophosphatemic rickets with hypercalciuria predict a key role for the sodium-phosphate cotransporter NaPi-IIc in maintaining phosphate homeostasis. Am J Hum Genet. 2006 Feb;78(2):179-92. doi: 10.1086/499409. Epub 2005 Dec 9.

    PMID: 16358214BACKGROUND

  • Nielsen LH, Rahbek ET, Beck-Nielsen SS, Christesen HT. Treatment of hypophosphataemic rickets in children remains a challenge. Dan Med J. 2014 Jul;61(7):A4874.

    PMID: 25123121BACKGROUND

  • Peacock M, Bolognese MA, Borofsky M, Scumpia S, Sterling LR, Cheng S, Shoback D. Cinacalcet treatment of primary hyperparathyroidism: biochemical and bone densitometric outcomes in a five-year study. J Clin Endocrinol Metab. 2009 Dec;94(12):4860-7. doi: 10.1210/jc.2009-1472. Epub 2009 Oct 16.

    PMID: 19837909BACKGROUND

  • Karp HJ, Vaihia KP, Karkkainen MU, Niemisto MJ, Lamberg-Allardt CJ. Acute effects of different phosphorus sources on calcium and bone metabolism in young women: a whole-foods approach. Calcif Tissue Int. 2007 Apr;80(4):251-8. doi: 10.1007/s00223-007-9011-7. Epub 2007 Apr 1.

    PMID: 17401693BACKGROUND

MeSH Terms

Conditions

Rickets, Hypophosphatemic

Interventions

Phosphates

Condition Hierarchy (Ancestors)

RicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersHypophosphatemiaPhosphorus Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Phosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsAnionsIonsElectrolytesPhosphorus Compounds

Study Officials

  • Niels Birkebæk., MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, multiple crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

November 21, 2017

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 21, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Publication.

Locations

DK(1)