CompletedPhase 3

Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Italy32 participantsStarted 2016-01-01

Plain-language summary

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Who can participate

Age range6 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Growth hormone deficiency clinically and biochemically demonstrated Exclusion Criteria: * Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up

What they're measuring

height

Timeframe: 12 months

weight

Timeframe: 12 months

body mass index

Timeframe: 12 months

Insulin growth factor-I

Timeframe: 12 months

glucose

Timeframe: 12 months

insulin

Timeframe: 12 months

glycated hemoglobin

Timeframe: 12 months

ISI Matsuda

Timeframe: 12 months

Oral disposition index

Timeframe: 12 months

Trial details

NCT IDNCT03033121

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-01

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