Status
Conditions
Treatments
About
Study design:
Double blind, randomized, placebo controlled study.The proposed study will consist of two main segments:
Segment 1
Population:
200 subjects and controls will be recruited to segment 1 of the proposed study, 100 at each group.
Participants will be recruited from healthy children who will be referred to either the institute for endocrinology or the gastroenterology unit, at Schneider Children's Medical Center for growth assessment, due to low height and weight, in whom, no gastrointestinal morbidity or other underlying cause was found.
Methods:
Randomization & Blinding:
Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the first 6 months of the study.
Treatment:
Participants in the intervention group will be treated with a nutritional supplementation standardized formula.Participants in the control group will be instructed to consume the same volume of formula as was calculated if they were in the intervention group.
Treatment duration:
The study will be divided into two treatment periods: 6 months of intervention versus active placebo followed with additional 6 months (an extension period), in which participants at the intervention group will be offered to extend the intervention period and participants at the control arm will be offered to switch to the intervention group.
Study Schedule:
Follow up visits will take place at 0, 3, 6, 9 and 12 months and will include:
Demographic data, medical history and growth data (month 0):
Demographic parameters, including birth date, gender, birth weight and length for gestational age, medical history and growth data, including height velocity, parent's and sibling's weight and height will be documented from patient's file.
Nutritional assessment
Anthropometric assessment (months 0, 3, 6, 9 12):
Laboratory parameters (months 0, 6 and 12):
Sleeping Questionaire
Segment 2:
86 subjects and controls will be recruited to segment 2 of the proposed study
Population:
Short and lean prepubertal children participating at segment 1 of the study and who are at study entry under 10th percentile in height, when the weight percentile is equal or smaller to the height percentile. Only participants from segment 1 who have siblings with normal height and body weight for age and gender, will be able to participate in segment 2 of the study
Control group 1:
Sibling of participants in segment 1 of the study, who have a normal height- above 25th percentile and normal BMI for age and gender- above 5th percentile and under 85th percentile.
Control group 2:
Healthy children from the community who have a normal height above 25th percentile and normal BMI for age and gender above 5th percentile and under 85th percentile
Segment 2 of the study will be designed as a case- control study and will focus on the eating patterns, sleeping patterns and quality of life of participants at segment 1 at time 0 month of the study, before the beginning of the nutrition intervention. These findings will be compared to data of a control group, which will be comprised of siblings of participants in segment 1, with normal height and body weight which are matched in age.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for participants at the intervention group (segments 1&2):
Exclusion Criteria for participants at the intervention group (segments 1):
Inclusion Criteria for participants at the control group (segments 2):
Exclusion Criteria for participants at the control group (segments 2):
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal