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Clinical study on the effect of vitamin K 2 on growth hormone therapy in children with idiopathic short stature

Clinical study on the effect of vitamin K 2 on growth hormone therapy in children with idiopathic short stature

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098193
Enrollment
Unknown
Registered
2025-03-04
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic short stature

Interventions

Control group:Conventional treatment with rhGH combined with vitamin D3 and calcium (specific drug type, dose, and method of use)
Treatment Group:In addition to the control group, 40ug of MK-7 was added

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 Those who meet the diagnostic criteria for ISS in the 9th edition of Zhu Futang Practical Pediatrics [height is more than 2 standard deviations lower than the reference value of normal children, growth rate is not less than 5cm/year, bone age is normal or delayed, and growth hormone peak is not less than 10ug/L]; 2 those aged 4-12 years; 3 those who have not used vitamin K or other related drugs in the three months before enrollment; the family members of the children all agree to this study.

Exclusion criteria

Exclusion criteria: 1 Children with pseudo-precocious puberty and partial precocious puberty; 2 Children with congenital malformations and intrauterine growth retardation; 3 Children with organic organ lesions or wasting diseases; 4 Children with malnutrition and skeletal dysplasia; 5 Children with soy allergy; 6 Children who did not receive treatment as required; 7 Children with mental disorders; 8 Children who were lost to follow-up.

Design outcomes

Primary

MeasureTime frame
Bone age;height; weight;Sexual development stage;

Secondary

MeasureTime frame
bone density ;insulin-like growth factor1;Percent change in absolute serum MK 7 concentration;

Countries

China

Contacts

Public ContactShuang Liang

The Second Hospital of Shandong University

liangshuang3508@163.com+86 176 6008 2768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026