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UP-study


- candidate number28256
- NTR NumberNTR6850
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2017
- Secondary IDsMPR17TA15103 Protocolnummer Nutricia Research
- Public TitleUP-study
- Scientific TitleBioavailability of phosphorus after oral intake of hypoallergenic infant formula with additional phosphate sources in healthy adult volunteers with a neutral stomach pH.
- ACRONYMUP
- hypothesisThe hypothesis formulation for the primary outcome parameter is:
-H0: The effect of using test product (Product A) is equal to the effect of using control product (Product B) with respect to the incremental area under the curve (iAUC0-360) of serum P.
-H1: The effect of using test product (Product A) is unequal to the effect of using control product (Product B) with respect to the incremental area under the curve (iAUC0-360) of serum P.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers
- Inclusion criteria- Age 18 and 40 years
- Non-Asian race*
- Body Mass Index (BMI) 18.5 and 24.9 kg/m2
- Willingness and ability to comply with the protocol
- Willingness to use a method of birth control during participation in the study (women only)
- Written informed consent
- Judged by the investigator to be in good health

* Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
- Exclusion criteria- Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery)
- Known renal or hepatic failure or known thyroid dysfunction
- Any known food allergy and/or food intolerance
- Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment
- Serum 25(OH)D of < 50 nmol/l
- Haemoglobin in men <7.5 mmol/l and in women <7.0 mmol/l
- Use of any medication within 3 weeks of screening except for oral contraceptive and incidental use of paracetamol and/or nonsteroidal anti-inflammatory drugs (e.g. ibuprofen and aspirin)
- Known hypersensitivity to omeprazole, substituted benzimidazoles or to any of its excipients, and fructose-intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency
- Use of nutritional supplements (other than vitamin D) within two weeks of Visit 1
- Unsuccessful placement of a cannula for taking blood samples at Visit 1.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-dec-2017
- planned closingdate31-mrt-2018
- Target number of participants24
- InterventionsDuration of intervention: 2 weeks
- Product A: New hypoallergenic infant formula in one serving
- Product B: Current hypoallergenic infant formula in one serving
- Primary outcomeThe primary outcome parameter in this study is the serum P iAUC0-360 [mmol/L*min] (product A compared to product B).
- Secondary outcomeThe secondary outcome parameters in this study are comparisons of product A and B on:
- Serum P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], Tmax [min]
- Serum Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], iAUC0-360 [mmol/L*min], Tmax [min]
- Serum creatinine [mol/L] (product A - B), Cmax, AUC0-360 [mol/L*min], Tmax [min]
- Serum iPTH [pmol/L] (product A - B), Cmax, AUC0-360 [pmol/L*min], Tmax [min]
- Serum AP [U/L] (product A - B), Cmax, AUC0-360 [U/L*min], Tmax [min]

- Urinary P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], iAUC0-370 [mmol/L*min] and Tmax [min]
- Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], iAUC0-370 [mmol/L*min] and Tmax [min] Urinary creatinine [mmol/L] (product A - B), Cmax, AUC0-370 [mmol/L*min] and Tmax [min]
- TimepointsV1 (day 1), V2 (day 7)
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Monique Visser
- CONTACT for SCIENTIFIC QUERIES Lucien Harthoorn
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research
- PublicationsNot yet available
- Brief summaryThis randomised, double blind, cross-over single-centre, single-dose study is designed to assess the bioavailability of phosphorus after oral intake of a new hypoallergenic infant formula compared to the bioavailability of phosphorus after oral intake of the current hypoallergenic infant formula.
- Main changes (audit trail)
- RECORD27-nov-2017 - 15-dec-2017


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