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临床试验/NCT05851313
NCT05851313已完成3 期

Role of Anthropometric Indices and Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response Against SARS-CoV-2 in Individuals Infected With COVID-19; A Randomized Control Trial

Sulaimany Polytechnic university2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年12月5日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect

研究概览

简要总结

The goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19.

The main question[s] it aims to answer are:

  1. BMI has role in reduce BioNTech, Pfizer vaccine side effect
  2. BMI has role in improve IgG titer
  3. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
  4. Vit-D supplementation has role in improve IgG titer

详细描述

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and size of supplements. The supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). Also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. From the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. Subjects were asked to continue to use supplements after the first vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants with COVID-19 positive tests.

排除标准

  • Who did not take the vaccine
  • who take one dose of the vaccine
  • who did not come back for another dose
  • subjects who in the last 6 months received vitamin or mineral supplementation
  • those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

结局指标

主要结局

Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect

时间窗: 16 weeks

Vitamin D supplement was given for 16 weeks

次要结局

  • Vit-D supplementation has role in improve IgG titer(16 weeks)

研究者

发起方
Sulaimany Polytechnic university
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hawal Lateef Fateh

Dr Hawal Lateef Fateh

Sulaimany Polytechnic university

研究点 (2)

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