Clinical trial: 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 (NCT01158352)

Eligibility criteria:
Inclusion Criteria for participants at the intervention group (segments 1&2):

          1. Girls aged 3-7 years old and boys aged 3-8 years old

          2. Prepubertal - tanner stage 1

          3. Height, weight and BMI < 10th percentile for age and gender

          4. Availability of growth velocity data for at least 4 months prior to study entry.

          5. Signing inform consent forms

        Exclusion Criteria for participants at the intervention group (segments 1):

          1. Diagnosis of GH Deficiency or treatment with GH

          2. Any known chronic disease or dysmorphic syndrome including: bone diseases, organic
             brain diseases, neurological disease, past or current malignancy, chronic cardial,
             renal or pulmonary problems

          3. Any known gastrointestinal problem including absorption problems

          4. Any known organic reason for slow growth

          5. Any chronic treatment with medication that might effects appetite (for example
             SSRI's), weight or Growth.

        Inclusion Criteria for participants at the control group (segments 2):

          1. Girls aged 3-8 years old and boys aged 3-9 years old

          2. Prepubertal - tanner stage 1

          3. Height ≥ 25th percentile for age and gender

          4. Proper proportion between weight and height- 5th ≤ BMI ≤ 85th

          5. Signing inform consent forms

        Exclusion Criteria for participants at the control group (segments 2):

          1. Diagnosis of GH Deficiency or treatment with GH

          2. Any known chronic disease or dysmorphic syndrome including: bone diseases, organic
             brain diseases, neurological disease, past or current malignancy, chronic cardial,
             renal or pulmonary problems

          3. Any known gastrointestinal problem including absorption problems

          4. Any known organic reason for slow growth

          5. Any chronic treatment with medication that might effects appetite (for example
             SSRI's), weight or Growth

          6. Children with growth faltering during the previous year
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 8 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction