This study's objective is 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.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the serum P AUC 0-360
[mmol/L*min] (product A compared to product B).
Secondary outcome
The 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], AUC0-360
[mmol/L*min], iAUC0-360 [mmol/L*min], Tmax [min]
- Serum creatinine [µmol/L] (product A - B), Cmax, AUC0-360 [µmol/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], AUC0-370
[mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min]
- Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-370
[mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min]
- Urinary creatinine [mmol/L] (product A - B), Cmax, AUC0-370 [mmol/L*min] and
Tmax [min]
Background summary
Cow*s milk allergy is the most common food allergy in infancy, affecting up to
5% of infants in their first year of life. For these children hypoallergenic
infant formula is available on the market, which decreases the chance of
allergic reactions. This hypoallergenic infant formula is also provided to
infants in medically complex patients in this age group, in combination with
medication and via different routes of administration. To optimize the uptake
of minerals of the current hypoallergenic infant formula for all target groups
using the formula, additional sources of phosphate have been added to the
formula. In this study the uptake of these minerals will be compared between
the two products.
Study objective
This study's objective is 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.
Study design
This is a randomised, double-blind, crossover, single-centre, single-dose study
Intervention
In this study two study products will be investigated:
- Product A: New hypoallergenic infant formula in one serving
- Product B: Current hypoallergenic infant formula in one serving
Study burden and risks
Subjects should take a total volume of ~475 ml of study product mixed with
water and flavoring during 2 visits. 4 days before visits 1 and 2 the subjects
should start esomeprazole intake at home. On the day before the visits,
subjects should not eat/drink food high in phosphorus and they have to come
fasted to the research center in the evening for intake of esomeprazole.
Afterwards, subjects eat a standardized diner. During the whole study period
subjects should take a daily dose of 10 µg vitamin D. At visits 1 and 2 a
nasogastric tube is placed and subjects should take again a dose of
esomeprazole, at several time points blood will be sampled, urine will be
collected, stomach pH assessed, and a short questionnaire should be completed.
Furthermore, a pregnancy test will be performed for women 3 times in total
(using a urine dipstick). During participation, subjects should adhere to a
number of rules related to medication- and supplement use and lifestyle.
Because the study will be performed in healthy adult volunteers and the product
that is being tested is normally safely used in a vulnerable population (namely
infants with food allergy), no severe adverse events are expected. However,
subjects may suffer from e.g. bloating and abdominal distention due to the fact
that the product is taken in a concentrated form. The risks of the other study
procedures are low and these will be performed / guided by qualified study
staff.
The burden for participants in this study is considered small and the benefits
of obtaining more knowledge on phosphorus and calcium absorption after intake
of the formula intended for use in children on a milk-free diet outweighs the
minimal burden.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
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 esomeprazole, and fructose-intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency
- Use of nutritional supplements (other than vitamin D) within two weeks of Visit 1
- Unsuccesfull placement of a cannula for taking blood samples at Visit 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63221.056.17 |