A 6 month, multi-center, randomized, double-blind, placebo-controlled parallel design human study for the evaluation of the efficacy and safety of HT042 on height promoting in low-height childre
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000736
- Lead Sponsor
- Korea Yakult Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 140
1) Men and women aged 6 to 8 years
2) children less than 25 percentile based on 2007 standard growth chart percentile due to idiopathic
3) People who signed the informed consent form before participating in the study
1)Children have Growth retardation caused by endocrine disorders (Growth Hormone deficiency, Hypothyroidism, type 1 diabetes mellitus etc.)
2)Children have Precocious Puberty(LH > 0.6 IU/L)
3)Children being treated with infected, tumor etc.
4)Children who have taken growth hormone within the last 4 weeks prior to the first visit of the study
5)Children who have taken functional foods or drugs within the last 2 weeks prior to the first visit of the study for growth
6)Patient has uncontrollable type 1 diabetes mellitus(Fasting blood glucose levels greater than 126 mg/dl)
7)TSH, T3, FT4 deviates from the normal value of the hospital
8)Patient has creatinine value exceeding 2 times of upper limit of the normal range at the hospital
9)Patient has AST(GOT) or ALT(GPT) value exceeding 2 times of upper limit of the normal range at the hospital
10)Subjects who are scheduled for another study during this study period
11)Subjects with any other health concerns
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Height
- Secondary Outcome Measures
Name Time Method Rate of growth;Height Standard Deviation Score(z-score);Bone age(X-ray);Growth Hormone;IGF-1(Insulin-Like Growth Factor-1, somatomedin C);GFBP-3(Insulin-Like Growth Factor-Binding Protein-3);Osteocalcin;1CTP(Cross-linked C-terminal telopeptide of type I collagen);BALP(Bone Alkaline Phosphatase);DPD(Urine Deoxypyridinoline)