Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial.

Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A

The Journal of clinical endocrinology and metabolism1 Sept 1999Cited by 141 (Europe PMC)

PMID10487666DOI10.1210/jcem.84.9.5942PepBankPUB-10487666

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children born SGA who remained prepubertal, 5-yr height SD-score gain was significantly greater with 6 than 3 IU GH/m2 x day.
In plain wordsIn children born SGA who remained prepubertal, the higher GH dose increased height SD score more than the lower dose.
Peptide
HGH (somatotropin)
Outcome
IncreasePrepubertal height SD-score dose response
Study
n: not reported in source
Comparator
3 IU/m2 x day
Outcome group
Linear growth · Endocrine and hormones
Studied dose
6 IU/m2 x day · 5 yearsAs given in this study (human).
Source sentences
Summary
Only in children who remained prepubertal during the study period was the 5-yr increase in height SD score (HSDS) for chronological age significantly higher in the study group receiving 6 compared to 3 IU GH/m2 x day.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766602
02HumanNon-randomized trialEfficacy outcome
In short children born SGA, almost every child reached normal height and target height SD-score ranges after 5 yr of GH.
In plain wordsIn short children born SGA, almost every child reached normal and target height ranges after five years of GH.
Peptide
HGH (somatotropin)
Outcome
IncreaseHeight normalization
Study
n = 79
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
After 5 yr of GH treatment almost every child had reached a height well within the normal range for healthy Dutch children and in the range of their target height SD score.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766601
03HumanNon-randomized trialEfficacy outcome
In short children born SGA, GH was associated with accelerated bone maturation regardless of dose.
In plain wordsIn short children born SGA, GH was linked to faster bone maturation at both doses.
Peptide
HGH (somatotropin)
Outcome
IncreaseBone maturation
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
GH treatment was associated with an acceleration of bone maturation regardless of the GH dose given.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766606
04HumanNon-randomized trialEfficacy outcome
In short children born SGA receiving GH, height SD score for bone age increased significantly.
In plain wordsIn short children born SGA receiving GH, height SD score for bone age increased.
Peptide
HGH (somatotropin)
Outcome
IncreaseHeight SD score for bone age
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
The HSDS for bone age and predicted adult height increased significantly.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766607
05HumanNon-randomized trialEfficacy outcome
In short children born SGA receiving GH, predicted adult height increased significantly.
In plain wordsIn short children born SGA receiving GH, predicted adult height increased.
Peptide
HGH (somatotropin)
Outcome
IncreasePredicted adult height
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
The HSDS for bone age and predicted adult height increased significantly.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766608
06HumanNon-randomized trialSafety outcome
In short children born SGA, GH treatment was well tolerated.
In plain wordsIn short children born SGA, GH treatment was well tolerated.
Peptide
HGH (somatotropin)
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
GH treatment was well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766609
07HumanObservational studyOther
In GH-treated children born SGA, 5-yr height SD-score gain was unrelated to spontaneous GH secretion.
In plain wordsIn GH-treated children born SGA, height gain was not linked to spontaneous GH secretion.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight gain relation to GH secretion
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
Remarkably, the 5-yr increment in HSDS for chronological age was not related to spontaneous GH secretion, maximum GH levels after provocation, or baseline insulin-like growth factor I levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766603
08HumanObservational studyOther
In GH-treated children born SGA, 5-yr height SD-score gain was unrelated to maximum provoked GH levels.
In plain wordsIn GH-treated children born SGA, height gain was not linked to maximum provoked GH levels.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight gain relation to provoked GH
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
Remarkably, the 5-yr increment in HSDS for chronological age was not related to spontaneous GH secretion, maximum GH levels after provocation, or baseline insulin-like growth factor I levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766604
09HumanObservational studyOther
In GH-treated children born SGA, 5-yr height SD-score gain was unrelated to baseline IGF-I.
In plain wordsIn GH-treated children born SGA, height gain was not linked to baseline IGF-I.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight gain relation to baseline IGF-I
Study
n: not reported in source
Outcome group
Linear growth · Endocrine and hormones
Studied dose
3 or 6 IU/m2 body surface-day · 5 yearsAs given in this study (human).
Source sentences
Summary
Remarkably, the 5-yr increment in HSDS for chronological age was not related to spontaneous GH secretion, maximum GH levels after provocation, or baseline insulin-like growth factor I levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomly and blindly assigned to 1 of 2 GH dosage groups (3 vs. 6 IU/m2 body surface-day).
Report a problemFND-1048766605

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT01697644

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Novo Nordisk A/Sn = 75Oct 1990 to May 2005

Foetal Growth Problem · Small for Gestational Age

Trial page ClinicalTrials.govUpdated 18 Jan 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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