在上一篇文章我们讲了医学期刊的临床试验研究论文的引言、文献综述以及研究空白与研究声明这三部分，今天继续完成接下来的部分
The Effects of Vitamin D Supplements on Obesity: A Randomized Clinical Trial Study
目录部分：
1. Introduction
2. Literature Review
3. Research Gap and Research Statement
4. Materials and Methods
4.1. Study Design and Ethical Approval
4.2. Participant Recruitment and Consent
4.3. Outcomes and Follow up
4.4. Statistical Analysis
5. Results
6. Discussion
4. Materials and Methods
材料与方法这部分是论文中最重要的部分，需要描述得足够详细，让其他研究人员能够根据论文重复你的实验。
4.1. Study Design and Ethical Approval
The study was a randomized double-blind placebo-controlled clinical trial study.The study was conducted between April 2015 and March 2017 at five different hospitals in the central United Kingdom. This study was approved by the National Health Service ethical committee and registered on www.clinicaltrial.org as NC 34532. The trial was conducted according to the guidelines of good clinical practice (GCP) and monitored by the GCP unit at the hospital.
第一步是研究设计。在临床试验论文中，必须要解释工作中采用的研究设计。在我们的实验中，这是一项随机、双盲安慰剂试验。
The study was a randomized double-blind placebo-controlled clinical trial study.
然后，可以谈论进行临床试验的地点和时间。
The study was conducted between April 2015 and March 2017 at five different hospitals in the central United Kingdom.
然后提供研究获得的伦理批准的详细信息。现在，在开始招募患者进行研究之前，必须在网站clinicaltrial.org上注册临床试验，且在文章中要提供注册号。要注意，如果临床试验未经注册，很多期刊都不会发表你的论文结果。
This study was approved by the National Health Service ethical committee and registered on www.clinicaltrial.org as NC 34532.
药品临床试验管理规范（GCP）是一套国际公认的质量标准，在进行涉及人的临床试验时必须遵循这些标准。最好提供有关谁负责为你的试验监控此情况的信息。
The trial was conducted according to the guidelines of good clinical practice (GCP) and monitored by the GCP unit at the hospital.
4.2. Participant Recruitment and Consent
Subjects were included if they met the following criteria: (1) BMI>25; (2) non-smoker; and (3) no history of diabetes. Subjects participating in weight loss programs were excluded from the study.A total of 50 subjects (25 male & 25 female) participated in the study at the age range of 15-60. The eligibility was evaluated by interview. They were asked to fill in a questionnaire to gather demographic information. An informed consent was obtained from all the participants.
确定研究中使用的纳入和排除标准非常重要。纳入标准定义了使受试者符合研究条件的特征。在我们的实验中，我们只包括体重指数大于25的非吸烟和非糖尿病受试者。
Subjects were included if they met the following criteria: (1) BMI>25; (2) non-smoker; and (3) no history of diabetes.
排除标准即使受试者无资格参加研究的特征。在我们的案例中，我们排除了参与减肥计划和服用膳食补充剂的受试者。
Subjects participating in weight loss programs were excluded from the study.
现在让我们详细介绍一下队列的特征，例如样本量、年龄、性别等。在我们的实验中，我们招募了50名年龄在15-60岁之间的受试者。
A total of 50 subjects (25 male & 25 female) participated in the study at the age range of 15-60.
此外，还可以提供一些有关招聘程序的信息。在我们的实验中，我们进行了一次面试，以确认是否符合资格。
The eligibility was evaluated by interview.
合格的参与者需要填写一份问卷，以便我们收集人口统计信息。
They were asked to fill in a questionnaire to gather demographic information.
招聘过程的另一个重要部分是获得参与者的知情同意。应向参与者提供有关试验的所有信息，包括益处和风险，以便他们决定是否参加试验。
An informed consent was obtained from all the participants.
4.3. Outcomes and Follow up
Participants were randomly divided into intervention and control groups, and received vit D supplements and placebo, respectively.Patients were assessed at 0, 6 and 12 months for a follow-up period of 1 year. BMI (primary outcome), waist circumference (secondary outcome) and BP (secondary outcome) were measured by a trained personal at each visit.
接下来我们需要解释一下参与者的分组依据。在我们的研究中，参与者被随机分为干预组和对照组。干预组服用维生素D补充剂，对照组服用安慰剂。
Participants were randomly divided into intervention and control groups, and received vit D supplements and placebo, respectively
我们的研究是双盲的，这意味着参与者和研究人员都不知道他们属于哪一组。为研究选择合适的随访期非常重要，因为较短的随访期会导致低估所测量的效果。另一方面，长期随访会增加受试者退出研究的风险。在我们的实验中，我们选择了12个月的随访期，每6个月进行一次测量。
Patients were assessed at 0, 6 and 12 months for a follow-up period of 1 year.
然后，我们必须说明在研究过程中对参与者测量的参数。我们测量了BMI、腰围和血压。BMI是主要结果。这意味着这是最重要的结果，我们将分析BMI值的变化，以证明或反驳我们的假设。次要结果，如腰围和血压，是我们进行的额外测量，为主要发现提供支持证据。
BMI (primary outcome), waist circumference (secondary outcome) and BP (secondary outcome) were measured by a trained personal at each visit.
4.4. Statistical Analysis
Analyses were performed with independent t-test and paired t-test. All data were shown as mean ± SE. In all analysis, P value <0.05 was considered statistically significant. The data were analyzed using SPSS 10.0 (http://www.spss.com) software.
最后就是研究中使用的统计分析和工具。在我实验中，我们使用独立样本t检验进行统计分析。独立样本t检验比较了维生素D组和安慰剂组两组的平均值。
Analyses were performed with independent t-test and paired t-test.
实验中的所有数据将以平均值±SE的格式表示。
All data were shown as mean ± SE.
我们还规定了统计显著性的定义；如果p值小于0.05，那么我们将认为差异具有统计学意义。我们还给出了本文中数据的格式。
In all analysis, P value <0.05 was considered statistically significant.
实验中的所有数据将以平均值±SE的格式表示。我们还提到了用于分析的统计包的名称。在我们的实验中，我们使用的是SPSS统计软件，版本号为10.0。
The data were analyzed using SPSS 10.0 (http://www.spss.com) software.
5. Results
From 50 participants, four subjects were excluded due to health issues. Two participants withdrew from the study due to personal reasons. Table 1 illustrates the characteristics of two groups participated in the study. In Figure 1, the BMI values are plotted as a function of duration for both groups.The results show that vitamin D supplementation caused a significant decrease in BMI (p<0.001). There was no significant difference in BP (p=0.71) between vitamin D (121 ± 3.1) and placebo groups (123 ± 4.2).
到了结果部分是你展示研究核心发现的地方，需要按照逻辑顺序呈现研究成果。但是要注意，不要在此处解释结果。在进入结果之前，需要向读者说明你在分析之前是否进行了任何预处理或数据清理。
在我们的案例中，由于健康问题，四名参与者不得不被排除在研究之外。两名参与者因个人原因退出。因此，这意味着我们处理的样本量比我们最初设定的样本量稍小。
From 50 participants, four subjects were excluded due to health issues. Two participants withdrew from the study due to personal reasons.
还可以用数字和表格展示你的数据，只在正文中详细说明最重要的结果。我们在一个表中展示了两个组的特征，且将BMI随时间的变化绘制成图表，并在论文中以数字形式呈现。
Table 1 illustrates the characteristics of two groups participated in the study. In Figure 1, the BMI values are plotted as a function of duration for both groups.
现在让我们从主要发现开始。在实验中，我们发现服用维生素D补充剂的队列中BMI显著下降。由于我们所说的是“显著下降”，我们必须提供一个p值。
The results show that vitamin D supplementation caused a significant decrease in BMI (p<0.001).
而下一个结果是两组之间的血压没有显著差异。我们还在文本中提供实际值。我们已经在方法部分提到，数据的格式为平均值±SE。
There was no significant difference in BP (p=0.71) between vitamin D (121 ± 3.1) and placebo groups (123 ± 4.2).
6. Discussion
Vitamin D supplementation significantly reduced the BMI over a 1 year period supporting the main hypothesis. The results agree well with the findings of existing studies [7-8].A negative association was observed between waist length and vitamin D supplementation. The findings are in contrast with the previous studies [9-10]. This outcome is likely due to the shorter duration of the study. It was quite surprising to find that there was a slight increase in BP among the vitamin D group. The result must be interpreted with caution due to limited data.
在讨论部分可以解释你的研究发现，并将结果与以前在此领域发表的工作进行比较，还可谈论局限性和未来工作方向。
可以以主要结果开始：在我们的实验中发现维生素D降低了BMI，这支持了主要的假设。
Vitamin D supplementation significantly reduced the BMI over a 1 year period supporting the main hypothesis.
接下来是说明这些发现是如何与该领域的现有研究相吻合的：在实验中发现，这些发现与之前发表的关于该主题的研究结果一致。
The results agree well with the findings of existing studies [7-8].
另外还有一个负面的结果：我们观察到腰围和维生素D之间的负相关。
A negative association was observed between waist length and vitamin D supplementation. The findings are in contrast with the previous studies [9-10].
然后给出你对这个负结果的解释：我们认为这是因为研究时间更短。
This outcome is likely due to the shorter duration of the study.
在实验当中还有一个意外的结果：我们发现服用维生素D补充剂的人群血压偏高。我们认为这是因为数据有限。
It was quite surprising to find that there was a slight increase in BP among the vitamin D group. The result must be interpreted with caution due to limited data.
The results demonstrated in this work provides a new perspective on the link between vitamin D and obesity from a clinical treatment perspective.To the best of our knowledge, this is the largest study to date to be conducted on health population. One of the most important limitation of the study is the small sample size. Larger clinical trials are needed to confirm the findings. This should be considered in future studies.
最后就是研究的意义。你需要解释你的发现将如何造福社会。还可以解释你的发现对现有知识体系的贡献以及对该领域未来研究的影响。然后添加一两行关于你的研究的新颖性，解释一下你的研究有什么独特之处。
The results demonstrated in this work provides a new perspective on the link between vitamin D and obesity from a clinical treatment perspective.
在我们的研究中，这是对健康人群进行的第一项研究。
To the best of our knowledge, this is the largest study to date to be conducted on health population.
然后要讨论局限性。每项研究都有局限性，我们要诚实地面对这些局限性，并解释未来的研究如何弥补你工作中的不足。在我们的案例中，主要的限制是我们的研究样本太小。
One of the most important limitation of the study is the small sample size.
在论文的最后，写上一两行关于未来可能的研究方向：我们可以进行更大样本的研究，以在未来再次确认我们的发现。
Larger clinical trials are needed to confirm the findings. This should be considered in future studies.
以上，就是一篇标准的实验研究论文的基础组成部分。
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