Comparative Evaluation of Three Vitamin D3 Formulations for Sequential Improvement of Vitamin D3 Levels throughout a period of 3-Months.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Weekly change in vitamin D3 levels up to 1 month
研究概览
简要总结
This is a prospective, open label, Phase IV study.
The study is planned to be conducted in 90 subjects with vitamin D3 deficiency (levels <20ng/ml) in India. After signing the informed consent form, the subjects will be screened for confirming the eligibility for study participation.
Patients will be screened on the basis of Demographics, Physical examination including vital signs, past medical history, medication history.
Eligible subjects shall be randomized into following 3 arms
Arm A (30 subjects): Oral Vitamin D3 granules (60000IU) every week
Arm B (30 subjects): Oral Vitamin D3 softgels (60000IU) every week
Arm C (30 subjects): Oral Vitamin D3 liquid nano-shots (60000 IU) every week
Subjects will be analyzed for vitamin D3 levels every week as per schedule mentioned in table.
Out of 30 subjects in Arm B (soft-gel capsule), 20 subjects who are willing to follow up for 6 more months. Those 20 subjects will be divided in 2 groups.
Group 1 (10 subject): Subjects continuing on monthly Vitamin D3 softegel capsule (60000 IU)
Group 2 (10 Subjetcs): Subject without any vitamin D3 therapy
Assessments
|Visit/ Time point
Assessments
| --- | --- | |Screening
Visit 1
Informed consent, eligibility, medical history, physical examination, baseline serum 25-hydroxyvitamin D levels
|Visit 2 Week 0
(Randomization Visit)
Clinical assessment (Vitamin D levels will not be repeated)
|Visit 3 Week 1
Measurement of serum 25-hydroxyvitamin D levels
|Visit 4 Week 2
Measurement of serum 25-hydroxyvitamin D levels
|Visit 5 Week 3
Measurement of serum 25-hydroxyvitamin D levels
|Visit 6 Week 4
Measurement of serum 25-hydroxyvitamin D levels
|Visit 7 Week 8
Measurement of serum 25-hydroxyvitamin D levels
|Visit 8 Week 12 (EOS)
Final assessment of serum 25-hydroxyvitamin D levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing to provide voluntary written informed consent.
- •2.If an individual is unable to provide informed consent due to reasons such as illiteracy, a Legal Authorized Representative (LAR) will be required to provide written informed consent.
- •3.Male or Female subjects between 18 to 65 years of age (both inclusive) 4.Vitamin D3 deficiency less than 20 ng/ml 5.Willing and able to comply with the protocol.
排除标准
- •1.Any Surgery or hospitalization within 28 days before enrolment 2.Known hypersensitivity to any component of the investigational product and other medications used in this study 3.Patients already on supplementation of calcium and/or Vitamin D 4.Patients suffering from acute or chronic infection(s) 5.BMI greater than 40 Kg/m2 6.Female patients who are pregnant or nursing 7.Patients with H/O concurrent disease or conditions like ESRD, pre-existing liver cell failure, terminally ill cancer or critically ill patients, which in the opinion of the investigator does not allow participation of the patient in this study 8.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
结局指标
主要结局
Weekly change in vitamin D3 levels up to 1 month
时间窗: 3 Months
次要结局
- 1.Total improvement of vitamin D3 levels over the period of 3 months(2.Percentage of people achieving optimal Vitamin D level at week 4,8 and week 12 in 3 groups.)
研究者
Dr Roshan Pawar
Alkem Laboratories Ltd