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A multicentre prospective autocontrolled real-world study of the efficacy and safety of calcium and zinc gluconate oral solution (Zinc Calcite) in the treatment of growth retardation in children.

A multicentre prospective autocontrolled real-world study of the efficacy and safety of calcium and zinc gluconate oral solution (Zinc Calcite) in the treatment of growth retardation in children.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099734
Enrollment
Unknown
Registered
2025-03-27
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

growth retardation in children

Interventions

Observation group:None

Sponsors

The First Affiliated Hospital of Hebei North University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1.Persons whose height is less than 1 SD below the median value of the reference population of the same age and sex; 2. Children between the ages of 3 (minimum age) and 10 (maximum age) male and female; 3. No previous growth hormone therapy; 4. Informed consent form signed by the child/subject's parent/legal guardian is obtained; 5. The child/subject's parent/legal guardian is able to communicate well with the investigator.

Exclusion criteria

Exclusion criteria: 1. The presence of diseases that affect the growth and development of children including but not limited to abnormal thyroid function abnormal parathyroid function growth hormone deficiency idiopathic dwarfism; 2. The presence of a disease that affects the child's standing or height measurement including but not limited to rickets scoliosis kyphosis; 3. Presence of serious systemic diseases such as severe cardiac pulmonary hepatic and renal insufficiency severe endocrine system diseases severe central nervous system and blood diseases; 4. Previous treatment with drugs that may interfere with growth hormone secretion or growth hormone action; 5. Known or suspected hypersensitivity to the investigational drug or related medications 6. The presence of overweight which was determined by BMI: children under 7 years of age with a BMI of +1SD and above were considered overweight; children over 7 years of age with a BMI greater than or equal to the age-specific threshold were considered overweight; 7. The investigator determines that the subject or parent/legal guardian is likely to be non-compliant with the implementation of the study; 8. Those whom the investigator deems unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Changes in diet;BMI(mean change value, improvement rate, recurrence rate);Height (mean change value improvement rate recurrence rate);

Countries

China

Contacts

Public ContactLiu Zhenkui

The First Affiliated Hospital of Hebei North University

liuzhenkui_hb@163.com+86 313 805 9228

Outcome results

None listed

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