The effect of vitamin b6 and omega-3 supplementation on hot flashes and mood states in menopause women

This study aimed to determine the effect of omega-3 and vitamin B6 supplements compared to omega-3 alone on menopausal symptoms.

This design is a randomized, double-blind, placebo-controlled clinical trial. Simple randomization method is used for randomization. This study is conducted on at least 60 postmenopausal women with menopausal symptoms who are randomly divided into two intervention groups and one control group.

This study will be conducted in the nutritional counseling and diet therapy office in Karaj city. After selecting the samples, none of the sample people know about randomization and the process of allocation to groups. Also, the researcher will not know the contents of the packages. Therefore, the present study is double-blind.

Eligibility criteria: Iranian nationality, literate, age 40-60 years, 12 months or more of menopause, natural menopause, complaints of hot flashes and mood problems at the time of the research; Conditions of non-entry: use of hormonal drugs and sedatives, recent experience of stressful factors such as death of close relatives or separation from spouse, etc., suffering from diseases such as diabetes, blood pressure and mental illnesses, history of spotting and uterine bleeding, treatment Active medicine for menopause symptoms, menopause caused by surgery, history of drug and tobacco use, sports activity more than 150 minutes per week.

The intervention group was randomly given daily omega-3 fatty acids and vitamin b6 (omega-3 1000 mg + vitamin B6 40 mg; n = 20) or daily omega-3 fatty acids (omega-3 1000 mg; n = 20) or Placebo (n = 20) will be given daily for 8 weeks.

Severity of menopause symptoms

Simple randomization method; In this method, each member of the desired society is selected with the same probability.To randomize the three groups, we generate a random number between 1 and 3 using the computer, according to the number of the studied sample; Then each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient number is written on each envelope, and the first patient who is registered in the study and enters the study is given the envelope corresponding to patient no. 1, patient number 2 will be given envelope number 2 and so on, and this work will continue until the end of the study sample. In order to maintain randomization, the person who prepares the envelopes (research assistant) will be different from the person who registers the patients and provides the envelopes to the patients (researcher).

After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. The numbered numbers are given to the researcher by the assistant of the researcher and the patients are entered into the study in the order of the numbers, and the researcher will not know about the contents of the packages. Therefore, the present study is double-blind. Also, the pill package of each group is the same in terms of shape, color and size and is delivered to the client in the package.

There is no further information.