NCT01158352

Brief Summary

Study design: Double blind, randomized, placebo controlled study.The proposed study will consist of two main segments:

  1. 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. 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
  3. 3.Demographic data, medical history and growth data (month 0):
  4. 4.Nutritional assessment
  5. 5.Anthropometric assessment (months 0, 3, 6, 9 12):
  6. 6.Height without shoes
  7. 7.Length
  8. 8.Weight with light cloths and without shoes
  9. 9.MAC
  10. 10.Body mass index (BMI) will be calculated from children's weight and height and age and gender specific BMI SDS will be calculated
  11. 11.Body composition assessment using the method of bioelectrical impedance
  12. 12.Laboratory parameters (months 0, 6 and 12):
  13. 13.Sleeping Questionaire

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

4 years

First QC Date

June 27, 2010

Last Update Submit

November 6, 2014

Conditions

GrowthLow WeightLow Height

Keywords

GrowthLow weightLow heightNutritional Formula

Outcome Measures

Primary Outcomes (1)

  • Height SDS (standard deviation score)

    standard deviation score of patient's height at 12 months

    At 12 months

Secondary Outcomes (8)

  • Weight SDS (standard deviation score)

    At 12 months

  • Weight/Height SDS (standard deviation score)

    At 12 months

  • BMI SDS (standard deviation score)

    At 12 months

  • Growth Velocity

    At 12 months

  • 5.Sleeping Questionaire

    At 12 months

  • +3 more secondary outcomes

Study Arms (2)

Nutritional supplemntation formula

EXPERIMENTAL

Nutritional supplementation standardized formula (powder added to liquids or food) containing 25% of recommended DRI for calories, high protein (20% of calories) and multi vitamins and mineral(25%-100% of DRI for recommended daily allowance or adequate intake)

Dietary Supplement: Nutritional supplementation formula

Placebo Comparator

PLACEBO COMPARATOR

Placebo low caloric formula (Powder added to liquids or food, without added vitamins and minerals

Dietary Supplement: Placebo Comparator

Interventions

Nutritional supplementation formulaDIETARY_SUPPLEMENT

Nutritional supplementation formula

Nutritional supplemntation formula
Placebo ComparatorDIETARY_SUPPLEMENT

Placebo low caloric formula (Powder added to liquids or food, without added vitamins and minerals

Placebo Comparator

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Girls aged 3-7 years old and boys aged 3-8 years old
  • Prepubertal - tanner stage 1
  • Height, weight and BMI \< 10th percentile for age and gender
  • Availability of growth velocity data for at least 4 months prior to study entry.
  • Signing inform consent forms

You may not qualify if:

  • Diagnosis of GH Deficiency or treatment with GH
  • 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
  • Any known gastrointestinal problem including absorption problems
  • Any known organic reason for slow growth
  • Any chronic treatment with medication that might effects appetite (for example SSRI's), weight or Growth.
  • Girls aged 3-8 years old and boys aged 3-9 years old
  • Prepubertal - tanner stage 1
  • Height ≥ 25th percentile for age and gender
  • Proper proportion between weight and height- 5th ≤ BMI ≤ 85th
  • Signing inform consent forms
  • Diagnosis of GH Deficiency or treatment with GH
  • 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
  • Any known gastrointestinal problem including absorption problems
  • Any known organic reason for slow growth
  • Any chronic treatment with medication that might effects appetite (for example SSRI's), weight or Growth
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical center

Petaach-Tikva, 49202, Israel

Location

Related Publications (2)

  • Yackobovitch-Gavan M, Lebenthal Y, Lazar L, Shalitin S, Demol S, Tenenbaum A, Shamir R, Phillip M. Effect of Nutritional Supplementation on Growth in Short and Lean Prepubertal Children after 1 Year of Intervention. J Pediatr. 2016 Dec;179:154-159.e1. doi: 10.1016/j.jpeds.2016.08.100. Epub 2016 Sep 30.

    PMID: 27697330DERIVED

  • Lebenthal Y, Yackobovitch-Gavan M, Lazar L, Shalitin S, Tenenbaum A, Shamir R, Phillip M. Effect of a nutritional supplement on growth in short and lean prepubertal children: a prospective, randomized, double-blind, placebo-controlled study. J Pediatr. 2014 Dec;165(6):1190-1193.e1. doi: 10.1016/j.jpeds.2014.08.011. Epub 2014 Sep 17.

    PMID: 25241181DERIVED

MeSH Terms

Conditions

Thinness

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Moshe Phillip, Prof

    Schenider Children's Medical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2010

First Posted

July 8, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

IL(1)