An interventional study of Phosphate tablets. and High cheese intake. in Hypophosphatemic Rickets, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
10 studies on the registry are indexed under Rickets, Hypophosphatemic; none are open to participants now.
Browse Rickets, Hypophosphatemic studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose.
Dietary Supplement: Phosphate tablets.
Cheese with an estimated phosphate content of 800 mg distributed over 5 meals.
Dietary Supplement: High cheese intake.
800 ml of milk daily corresponding to approximately 800 mg phosphor per day.
Dietary Supplement: High milk intake.
Serum phosphate.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Time frame: Three days.
Fibroblast growth factor 23.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Time frame: Three days.
Parathyroid hormone.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Time frame: Three days.
Total calcium.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Time frame: Three days.
Basic phosphatase.
Evaluated in blood samples. Evaluated after three days of treatment, where we collected blood 5 times through out one day.
Time frame: Three days.
Urine phosphate.
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.
Time frame: One day.
Urine calcium.
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.
Time frame: One day.
Plan to share: Yes — Publication.
Ran from Aug 2015 to primary completion in Jun 2016, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.