Assessment and correlation of Vitamin D level with growth status as measured by CVMI and IGF-1 level in 10-14 years old individuals.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The study aims to determine whether vitamin D levels are significantly associated with physical growth and maturation markers in children aged 10-14 years.
研究概览
简要总结
This cross-sectional analytical study will evaluate 50 orthodontic patients ages between 10 to 14 years presenting to the Orthodontic Department.
All the patients who have had lateral cephalograms obtained for their orthodontic treatment will be selected for the study.
All the patients and their parents will be informed about the study and the parents will sign the informed consent forms.
After obtaining the parents consent, questionnaire will be provided to the patient to analyze the dietary intake of Vitamin D and exposure to sunlight, patients will then undergo blood tests in the designated laboratory to determine their serum 25-hydroxy vitamin D level and IGF-1 level.
The patients and their parents will be informed of the test results and will be educated about the role of vitamin D in the body.
The test results will then be provided to the parents, and they will be referred for medical consultation if needed.
To determine the skeletal age of patients, CVM stage analysis of the second, third and fourth cervical vertebrae (CV2-CV4) on lateral cephalograms will be performed.
The investigator will be blinded to the chronological age and serum vitamin D level of patients and will independently determine the CVM stage and the skeletal age.
Cervical vertebral maturation stage (C2-C4) will be evaluated, as presented by Baccetti modified protocol.
The blood sample that we obtained will aid us to determine the level of Insulin like growth factor-1(IGF-1) with the help of DRG IGF-1 600 ELISA kit.
The DRG IGF-1 600 ELISA Kit is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding.
• Data will then be statistically compared to correlate level of Vitamin D with growth status of the patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age of the patient between 10-14 years.
- •2.Patients having lateral cephalograms taken for orthodontic treatment.
- •3.Patient willing to participate in the study.
排除标准
- •1.History of systemic diseases, medication intake, craniofacial syndromes.
- •2.Patient not willing to perform blood test.
- •3.Patients who have taken Vitamin D supplements in last 2 years.
- •4.Patients who are currently on Vitamin D supplements.
- •â€¢ Patients with Endocrinal disorders.
结局指标
主要结局
The study aims to determine whether vitamin D levels are significantly associated with physical growth and maturation markers in children aged 10-14 years.
时间窗: at 6 months
次要结局
- a) To associate Vitamin D level with the body mass index.(b) To associate Vitamin D level with growth pattern.)
研究者
Dr Manika Jaiswal
Ranjeet Deshmukh Dental College and Research centre