Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children
Condition: Growth; Low Weight; Low Height
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      Study design:

      Double blind, randomized, placebo controlled study.The proposed study will consist of two
      main segments:

        1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutritional
           supplementation standardized formula, in short and lean prepubertal children on weight
           SDS, height SDS, BMI SDS and growth velocity

        2. Segment 2 is aimed to explore the eating behavior of idiopathic short stature and lean
           prepubertal children against their sibling who have a normal height and body weight and
           to find out whether there is a difference in eating patterns and quality of life between
           idiopathic short stature and lean prepubertal children and children with normal height
           and body weight

      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:

        1. 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.

        2. Nutritional assessment

        3. Anthropometric assessment (months 0, 3, 6, 9 12):

             1. Height without shoes

             2. Length

             3. Weight with light cloths and without shoes

             4. MAC

             5. Body mass index (BMI) will be calculated from children's weight and height and age
                and gender specific BMI SDS will be calculated

             6. Body composition assessment using the method of bioelectrical impedance

        4. Laboratory parameters (months 0, 6 and 12):

        5. 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.
    


Intervention name(s): Nutritional supplementation formula; Placebo Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutritional supplementation formula; Placebo low caloric formula (Powder added to liquids or food, without added vitamins and minerals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Growth; Low weight; Low height; Nutritional Formula