Nutritional RequirementsNCT00292812
Clinical Effects of a Nucleotides-Supplemented Infant Formula
A study testing Nutritional supplementation (nucleotides) in people with Nutritional Requirements, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Nutritional Requirements
- What is being tested?
- Nutritional supplementation (nucleotides)
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborns aged 0-30 days.
Who cannot join
- Prematurity
- Chronic illness
- Failure to thrive
- Milk allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.
Read the detailed description
Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters:
- Growth percentiles.
- Behaviour and infantile colic.
- Bowel habits.
- Side effects.
- Conditions
- Nutritional Requirements
- Being tested
- Nutritional supplementation (nucleotides)
- Keywords
- Infant nutrition, Nucleotides, Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementation (nucleotides)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth percentiles, Behaviour and infantile colic, Bowel habits.
Secondary outcomes (1)
Side effects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startMar 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional RequirementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Materna Laboratories
- Investigators
- Zvi Weizman, MD, Principal investigator, Head, Pediatric GI and Nutrition Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292812
- Sponsor's protocol ID
- Sor4123ctil
- Status last verified
- May 2007
- First submitted
- 15 Feb 2006
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
- ClinicalTrials.gov ID
- NCT00292812
- Acronym / sponsor ID
- Sor4123ctil
- Conditions
- Nutritional Requirements
- Keywords
- Infant nutrition, Nucleotides, Infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Materna Laboratories
- Study start
- Mar 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.
Detailed description
Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters:
- Growth percentiles.
- Behaviour and infantile colic.
- Bowel habits.
- Side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy newborns aged 0-30 days.
Key exclusion criteria (4 listed)
- Prematurity
- Chronic illness
- Failure to thrive
- Milk allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplementation (nucleotides) | Drug | – |
Primary outcome
Growth percentiles, Behaviour and infantile colic, Bowel habits.
1 secondary outcome
Side effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Weizman, MD principal investigator
Head, Pediatric GI and Nutrition Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation (nucleotides) in people with Nutritional Requirements, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth percentiles, Behaviour and infantile colic, Bowel habits.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2007.