Vitamin D Dosing and Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in vitamin D levels with specified dose and route of administration, at define intervals
研究概览
简要总结
The purpose of the study is determination of effective vitamin D replacement strategy in vitamin D deficiency states with currently available preparations in Pakistan & to determine the cost effective monitoring strategy with urinary calcium excretion serving as a surrogate marker of achievement of vitamin D sufficiency state.
The study will be conducted at the out-patient Endocrinology Clinics of the Aga Khan University Hospital, Karachi, Pakistan. All patients seen in endocrine clinics with Vitamin D level less than 20 ng and do not have any of exclusion criteria mentioned below will be eligible for recruitment in the study. The study participants will be randomly assigned into 4 groups for intervention to receive intramuscular or oral Vitamin D in 200,000 or 600,000 units as per group allocation. Each group will comprise of 25 participants.
Group 1: Vitamin D3 600,000 units IM and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
Group 2: Vitamin D3 600,000 units orally and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
Group 3: Vitamin D3 200,000 units IM initially and then every 2 monthly for 2 months if levels remain < 30 ng/ml.
Group 4: Vitamin D3 200,000 units orally initially and then every 2 monthly for 2 times if levels remain < 30 ng/ml.
All patients will be prescribed elemental Calcium 1 gram /day. Vitamin D levels along with the other biochemical parameter and random urine for calcium & creatinine will be checked at 00, 02, 04, 06 and 12 months.
详细描述
Vitamin D deficiency (VDD) has resurfaced as a significant public health problem in recent years. In Pakistan and as well in the region, VDD is very prevalent despite adequate sunshine throughout the year. Prevalence of VDD of 92% and 81% in ambulatory patients has been reported from centers in Karachi and Lahore recently. Reports previously have also demonstrated VDD from various regions of Pakistan, a study conducted at tertiary care hospital in Karachi found that 55% of healthy breast fed infants and 45% of nursing mothers had very low levels of vitamin D. Another study conducted in Hazara division found rickets as a common problem in children despite abundant sunlight.
There are several areas of controversy which has great relevance for the investigators community like what level of vitamin D should be considered as deficiency, what are the daily requirements of vitamin D and how VDD should be corrected. Generally level below 20ng/ml is considered deficient and levels between 21 and 29 ng/ml is considered relative insufficiency as depicted by intestinal calcium absorption and nadir levels of parathyroid hormone.
Determination of the daily intake required to attain adequate serum 25(OH)D concentrations are compounded by the wide variability in the dose-response curve and basal 25(OH)D concentrations.
There is no universally accepted method of correcting VDD, In US the available preparation is 50,000 units of ergocalciferol, given weekly or three times per week for total of 300,000 units. Several strategies has recently been studied, a study from southern Brazil demonstrated that a single 300 000 IU oral dose of vitamin D3 was more effective than 800 IU per day to increase serum 25(OH)D levels in elderly persons, living in a low-income housing unit.
Contrary to this comparison of the equivalent oral doses of vitamin D3 600 IU/day, 4200 IU/week and 18,000 IU/month on vitamin D status showed that daily dose was more effective than a weekly dose, and a monthly dose was the least effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with Vitamin D level less than 20 ng/dl
排除标准
- •Patients who have received vitamin D injection in last 03 months.
- •Patients with hypercalcemia (corrected calcium > 10.6 mg/dl)
- •Known Malignancy.
- •Known case of CLD or serum ALT > 3 times ULN
- •Patients with creatinine > 2.0 mg/dl.
研究组 & 干预措施
Vitamin D 600,000 IM
Vitamin D3 600,000 units will be given by intramuscular injection
干预措施: Vitamin D3 600,000 units IM (Drug)
Vitamin D 600,000 orally
Vitamin D3 600,000 units will be given orally
干预措施: Vitamin D3 600,000 Orally (Drug)
Vitamin D 200,000 IM
Vitamin D3 600,000 units will be given by intramuscular injection
干预措施: Vitamin D3 200,000 units IM (Drug)
Vitamin D 200,000 orally
Vitamin D 200,000 units will be given orally
干预措施: Vitamin D3 200,000 Orally (Drug)
结局指标
主要结局
Change in vitamin D levels with specified dose and route of administration, at define intervals
时间窗: 02, 04, 06 and12 months
次要结局
- Differences in the random urinary calcium to creatinine ratio in the untreated and treated state and its correlation with vitamin D levels(00, 02, 04, 06 and 12 months)
研究者
Muhammad Qamar Masood
Assistant Professor, Department of Medicine
Aga Khan University