Comparison of the effectiveness of oral vitamin D and placebo on sleep quality in menopausal women

Determining the effect of oral vitamin D supplementation on sleep quality in menopausal women

A controlled, double-blind, randomized, phase 3 clinical trial with parallel groups on 52 patients. A random permutation table was used for randomization.

Demographic information, Petersburg sleep quality questionnaire, and information about food intake will be completed through interviews between the referring individuals. Then, eligible individuals will enter the study by obtaining written informed consent. Fasting blood samples of 5 cc will be taken from the samples between 8-10 am to determine the level of vitamin D. In the next stage, samples that are at a vitamin D deficiency level will be assigned to two experimental and control groups using a four-way block method. Vitamin D supplementation of 1000 units will be 2 times daily for 8 weeks. During this period, the control group will also use two placebos daily. Finally, after 8 weeks, the Petersburg sleep quality questionnaire and information about food intake will be completed again in both intervention and control groups, and fasting blood samples of 5 cc will be taken again to determine the level of vitamin D.

Inclusion criteria: Poor sleep quality )، Vitamin D level below 20 units Exclusion criteria: Presence of any physical or mental illness that causes sleep disturbance (such as shortness of breath, thyroid disorder, depression, etc.)؛Sensitivity to vitamin D supplements, other vitamins, drug sensitivity

Oral vitamin D supplement of 1000 units and placebo will be used. The vitamin D supplement of 1000 units will be taken twice daily for 8 weeks. During this period, the control group will also take two placebos daily.

Percentage of people whose Petersburg questionnaire score is above 5

Menopausal women referring to health centers in Ahvaz city who met the inclusion criteria were selected by convenient non-probability sampling, and the method of assigning the drug and placebo to the patients was performed randomly and by the method of randomized permutation blocks with a block size of 4 using a table related to random permutations. Randomization in this study was performed as follows: First, blocks with a fixed size of 4 (intervention group: A and control group: B) and then, all possible permutations for this block (six possible permutations) AABB, ABAB, BABA, BBAA, ABBA, BAAB will be prepared in advance in a random permutation table. When each participant entered the study, a block was randomly selected from the table (for example, using a random number generated by the software or by drawing lots from the blocks in the table or by rolling dice). The order of the letters in the selected block determined the order of assignment of the participants to the different groups A, B. In this way, after the participant entered, one person was definitely assigned to each group and imbalance between groups was prevented. This process was repeated for all participants until the desired sample size was achieved (given that the number of participants was 52, divided by 4, 13). The randomization list was prepared by a statistician. The reason for using block randomization is that it is recommended to use the block method if the sample size is small. This method leads to the selection of balanced groups and whenever the study is stopped, the same number of people will be in the groups. The drug and placebo used in this study were placed in sealed envelopes according to the randomized list, according to the corresponding codes, and then assigned to each patient who entered the study.

The researcher will visit the research environment with the aim of collecting data, identify eligible women, and explain to the participants about the objectives of the study and the confidentiality of the individuals' characteristics. If they wish to participate in the study, a written consent form will be signed by the volunteer. The researcher and the participant in this study are aware of whether the vitamin D supplement is a drug or a placebo. The tablets were prepared by the pharmacist and coded with codes A and B. The drug and placebo were identical in terms of appearance, such as packaging and color. The nature of the drug and placebo was revealed after analyzing the results. Each person was assigned to the control or placebo group based on a random number table, and the chances of individuals being in each group were completely equal.

Only part of the data, such as information related to the main outcome, can be shared after de-identifying individuals.

Access period starts 6 months after results are published.

Researchers working in academic and scientific institutions

In situations where the data is used for academic research

ghazanfarizahra04@gmail.com

The request is made by sending an email and it takes about 14 days for the data to reach them.