- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292812
Clinical Effects of a Nucleotides-Supplemented Infant Formula
October 22, 2007 updated by: Soroka University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beer-Sheva, Israel, 84101
- Soroka Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy newborns aged 0-30 days.
Exclusion Criteria:
- Prematurity
- Chronic illness
- Failure to thrive
- Milk allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Growth percentiles, Behaviour and infantile colic, Bowel habits.
|
Secondary Outcome Measures
Outcome Measure |
---|
Side effects.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zvi Weizman, MD, Head, Pediatric GI and Nutrition Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
February 15, 2006
First Submitted That Met QC Criteria
February 15, 2006
First Posted (Estimate)
February 16, 2006
Study Record Updates
Last Update Posted (Estimate)
October 23, 2007
Last Update Submitted That Met QC Criteria
October 22, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sor4123ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nutritional Requirements
-
Ohio State UniversityRecruitingNutritional RequirementsUnited States
-
Ohio State UniversityActive, not recruitingNutritional RequirementsUnited States
-
Tianjin Medical UniversityRecruitingNutritional RequirementsUnited States, China, Switzerland
-
Tianjin Medical UniversityCompletedIodine Deficiency | Nutritional Requirements
-
Chen WenShandong Institute for Endemic Disease Control and ResearchRecruitingNutritional RequirementsChina
-
Tianjin Medical UniversityNot yet recruitingNutritional RequirementsChina
-
Tianjin Medical UniversityShandong Institute for Endemic Disease Control and ResearchCompletedStudy on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in ChildrenNutritional RequirementsChina
-
USDA Grand Forks Human Nutrition Research CenterNational Cancer Institute (NCI)CompletedNutritional RequirementsUnited States
-
University of AlbertaMead Johnson NutritionCompletedFocus: Nutritional Requirements for InfantsCanada
-
Auburn UniversityNot yet recruitingNutrition Status | Sports Nutritional Sciences | Nutritional Requirements
Clinical Trials on Nutritional supplementation (nucleotides)
-
Seoul St. Mary's HospitalCompletedProtein-Energy MalnutritionKorea, Republic of
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)CompletedEsophagitis | Mucositis | Malignant NeoplasmUnited States
-
Burke Rehabilitation HospitalCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnClinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage IIIA Esophageal Adenocarcinoma... and other conditionsUnited States
-
Jinling Hospital, ChinaCompletedMuscle Loss | Nutritional Support
-
Vanderbilt UniversityCompletedEnd Stage Renal DiseaseUnited States
-
Vanderbilt UniversityCompletedEnd Stage Renal DiseaseUnited States
-
Vanderbilt UniversityCompletedEnd Stage Renal DiseaseUnited States
-
Taylor's UniversityNational Kidney FoundationCompletedEnd Stage Renal Disease on Dialysis | Muscle Wasting
-
Centre Antoine LacassagneCompletedHead and Neck Cancer | Malnutrition | InfectionFrance