Public health program to assess the prevalence of Vitamin-D deficiency and its management with homoeopathic medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,600
- 试验地点
- 14
- 主要终点
- Change in serum Vitamin-D levels
研究概览
简要总结
This is a public health program where in within the identified blocks and villages screening for Vitamin D deficiency would be undertaken to identify the prevalence of Vitamin D deficiency/insufficiency as well as toxicity levels in the participants. The participants identified with vitamin D deficiency/insufficiency, which is serum vitamin D levels between 20 ng/ml to 30 ng/ml, will be recruited to the study. Cluster randomization will be conducted where in one group will be advised Individualised Homoeopathic Medicine and the other group will be given Calcarea Phosphoricum 6x. Along with this both groups will be given dietary advice as well as required IEC material will be provided to ensure nutritional compliances. No new drugs will be used in the study. Vitamin D levels will be again tested at 6 months and at 12 months post intervention to assess change in the vitamin D levels in order to identify the usefulness of homoeopathic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals coming to the medical camps for health checkups.
- •Children aged 6 to 17 years, and adult individuals aged 18 to 65 years of both sexes.
- •Persons willing to participate in the program and give consent (6 years to less than 12 years shall provide verbal assent & consent of parent also their parent or guardian can answer the questions for them, 12 years to less than 18 years shall provide written assent and consent of parent and adults of 18 to 65 years shall provide written consent) to draw blood for further examinations.
- •Persons who can be interviewed directly and who can respond to the questions of the survey Persons with vitamin D Insufficiency (more than 20 to less than 30 ng/ml).
排除标准
- •Persons above 65 years of age Persons with self-reported severe bleeding disorders such as haemophilia or thrombocytopenia, or Anticoagulant Medication (currently or in the last 3 months) Participants exhibiting symptoms of active infection, such as fever, chills, or localized signs of infection at the venipuncture site.
- •Participants with severe deficiency of Vitamin D (less than 5 ng/ml), Moderate deficiency (6-19 ng/ml) and toxicity Participants unable to come for regular follow-ups for a minimum of two follow-ups.
- •Participants refusing consent for the homoeopathic treatment.
- •Pregnant and lactating women.
- •Persons with identified Hepato-renal conditions.
结局指标
主要结局
Change in serum Vitamin-D levels
时间窗: Baseline, at 6 months and at 12 months
次要结局
- prevalence of Vitamin D levels(baseline)
- Change in serum Calcium levels(baseline, at 6 months and at 12 months)
- Change in serum Phosphate levels(Baseline, at 6 months and at 12 months)
- Change in serum Magnesium levels(Baseline, at 6 months and at 12 months)
- Change in serum Uric Acid levels(Baseline, at 6 months and at 12 months)
- Change in Alkaline Phospatase levels(Baseline, at 6 months and at 12 months)
研究者
Dr Renu Mittal
Central Council for Research in Homoeopathy