Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy

NCT03053687 | Recruiting

• 1 other identifier: rmc082116ctil
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The Proposed study is a double blind, randomized, placebo controlled study The aim of the study is to evaluate the effect of combined Growth Hormone (GH) treatment \& nutritional formula supplementation versus GH \& placebo on growth parameters in 64 children with Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment. In this trial GH is a background treatment (non-investigational medicinal product. Participants may be treated with any of the commercial GH products approved in Israel for the indication of IGHD. 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 study. The randomization will be done according to gender and tanner stage. Participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (Powder added to water) The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.

Conditions

IGHD - Isolated Growth Hormone Deficiency; Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Weight Standard Deviation Score (SDS)

  at 6 months

Secondary Outcomes (3)

• Height-SDS

  at 12 months

• Weight SDS

  at 12 months

• BMI SDS

  at 12 months

Other Outcomes (1)

• Body composition

  at 12 months

Study Arms (2)

Nutritional Standardized Supplementation Formula

EXPERIMENTAL

Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake

Dietary Supplement: Nutritional supplementation standardized formula

Placebo

PLACEBO COMPARATOR

Low caloric formula (Powder added to water) without added vitamins and mineral

Dietary Supplement: Placebo

Interventions

Nutritional supplementation standardized formula DIETARY_SUPPLEMENT

Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake

Nutritional Standardized Supplementation Formula

Placebo DIETARY_SUPPLEMENT

Low caloric formula (Powder added to water) without added vitamins and mineral

Placebo

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml
• Boys: testicular volume \< 8ml; Girls: breast ≤ Tanner 3
• weight SDS \< 0
• BMI SDS \< 50 precentile for age and gender
• Signing inform consent forms

You may not qualify if:

• Other indication for GH treatment.
• Bone age: boys\>13.5, girls\>11.5.
• Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders.
• Any known gastrointestinal problem including absorption problems.
• Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use
• Any eating disorders and/or psychiatric disorder

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schnider children's medical center

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Moshe Phillip, Prof, MD

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Phillip, Prof, MD

CONTACT

972-3-9253282; mosheph@clalit.org.il

Alona Hamou, Msc

CONTACT

972-3-9253747; alonah@clalit.org.il

Study Design

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

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 15, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)