Background: Premenstrual syndrome (PMS) alludes to a cyclic advent of somatic and psychiatric symptoms that affect some women of reproductive age. Some studies demonstrated that vitamin D was associated with premenstrual symptoms. Objective: The aim of this study was to evaluate the effect of vitamin D supplementation in the treatment of PMS in vitamin D-deficient young girls. Methods: In this randomized double-blind placebo-controlled trial, 130 vitamin D-deficient girls aged 18–30 years, with PMS, were randomly divided into 2 groups and received a 2,000 IU vitamin D tablet (n = 64) or a placebo (n = 66) every other day for 12 weeks. At the beginning and at the end of week 12, serum 25(OH)-D, premenstrual symptoms, anthropometric indices, dietary intake, physical activity level, and sun exposure were evaluated. Statistical analysis was performed using SPSS version 20. p < 0.05 was considered statistically significant. Results: Serum 25(OH)-D levels were significantly elevated in the vitamin D group in comparison to the placebo group after 12 weeks (p < 0.001). There was no significant difference between the 2 groups with regard to 14 symptoms of PMS after 12 weeks of intervention, even after adjustment for the baseline values of anxiety, weeping, and hypersomnia (for all symptoms, p > 0.05). However, in the vitamin D group, scores of nervousness (p < 0.001), job activity reduction (p = 0.01), social activity reduction (p = 0.01), fatigue (p < 0.001), and physical symptoms (p = 0.00) were reduced at the end of the intervention, and these changes were statistically significant compared to baseline. However, these alterations did not reach significance compared with the placebo group (p > 0.05). Conclusion: It seems that 2,000 IU vitamin D consumption in the vitamin D-deficient young girls with PMS every other day for 12 weeks had no significant impact on other PMS symptoms.

Hintergrund: Unter dem Begriff des prämenstruellen Syndroms (PMS) wird das zyklische Auftreten somatischer und psychischer Beschwerden bei einem Teil der Frauen im gebärfähigen Alter zusammengefasst. Einige Studien belegen einen Zusammenhang zwischen der Vitamin-D-Ver-sorgung und den prämenstruellen Symptomen. Ziel: Das Ziel dieser Studie war es zu beurteilen, wie die Supplementierung von Vitamin D im Rahmen der Behandlung des PMS bei jungen Frauen mit Vitamin-D-Mangel wirkt. Methoden: In dieser randomisierten, doppelblinden, placebokontrollierten Studie erhielten 130 junge Frauen im Alter von 18–30 Jahren, die an Vitamin-D-Mangel und PMS litten, nach Randomisierung in 2 Gruppen für 12 Wochen alle 2 Tage entweder 2’000 IU Vitamin-D-Tabletten (n = 64) oder Placebo (n = 66). Zu Studienbeginn und nach Ablauf der 12 Wochen wurden Serum-25(OH)-D, prämenstruelle Symptome, anthropometrische Kennzahlen, Ernährung, Grad der körperlichen Aktivität und Sonnenexposition evaluiert. Die statistische Auswertung erfolgte mit SPSS Version 20. Ein p-Wert < 0,05 galt als statistisch signifikant. Ergebnisse: Die 25(OH)-D-Werte im Serum waren in der Vitamin-D-Gruppe nach Woche 12 signifikant höher als in der Placebogruppe (p < 0,001). Im Hinblick auf 14 der untersuchten PMS-Symptome bestand nach dem 12-wöchigen Behandlungszeitraum kein signifikanter Unterschied zwischen den Gruppen, auch nach Bereinigung um die Ausgangslage bei den Parametern Angstgefühle, Weinen und Hypersomnie (bei allen Symptomen, p > 0,05). Die Scores für Nervosität (p < 0,001), Einschränkung der Ar-beitsaktivität (p = 0,01), Einschränkung der sozialen Aktivi-tät (p = 0,01), Erschöpfung (p < 0,001) und körperliche Beschwerden (p = 0,00) waren zwar am Ende des Behandlungszeitraums in der Vitamin-D-Gruppe niedriger als zu Studienbeginn, und diese Veränderungen waren statis-tisch signifikant. Im Vergleich zur Placebogruppe waren die Veränderungen jedoch nicht signifikant unterschiedlich (p > 0,05). Schlussfolgerung: Es scheint, dass die Zufuhr von 2,000 IU Vitamin D alle 2 Tage für 12 Wochen bei jungen Frauen mit Vitamin-D-Mangel und PMS keine signifikanten Auswirkungen auf die PMS-Symptomatik hatte.

Schlüsselwörter Vitamin D, Prämenstruelles Syndrom, Junge Frauen, PSST-Fragebogen

Premenstrual syndrome (PMS) commences during adolescence and might be one of the most common disorders that impact on normal lifestyle and performances in young women. PMS is described by different symptoms occurring during the luteal phase of the menstrual cycle and recovering at, or within a few days from, the onset of menstruation [1]. Symptoms are various and usually include irritability, mood alterations, anxiety, and depression; physical symptoms, such as breast tenderness, bloating, and headaches; and behavioral symptoms, such as insomnia, alterations in appetite, and difficulty concentrating. While pharmacologic treatments, such as anti-depressants and oral contraceptives, are commonly used to treat PMS, these have considerable side effects and none has a reported efficacy higher than 60–70% [2, 3]. Because of these reasons, effective and nonpharmacological strategies for preventing and treating PMS are required.

Previous studies have investigated the role of vitamin D in preventing and/or improving mood and gynecologic disorders that share ordinary properties with PMS. Some studies have demonstrated a reverse relationship between vitamin D level and risk of depression [4, 5], fibromyalgia [6], dysmenorrhea [7], and uterine fibroids [8, 9]. However, it remains unclear whether vitamin D alone may be beneficial for preventing or treating PMS.

Thus, on the basis of these findings, the current study was planned to assess the effect of vitamin D supplementation on the severity of symptoms associated with PMS in vitamin D-deficient young girls.

This study was a randomized, double-blind, and placebo-controlled trial. Participants were recruited from university students who suffered from PMS. Volunteers could participate in the study if they were healthy girls, aged 18–30 years; had serum 25-(OH)-D <20 ng/mL; had normal menstrual cycle and bleeding during the last 3 months (3–7 days of bleeding); had regular menses and PMS according to a questionnaire and recorded the symptoms for 3 successive cycles; had a body mass index (BMI) between 18.5 and 34.9 kg/m2; were not taking vitamin D or any nutrient supplement, laxative, or hormone medication; and were not suffering from any chronic or mental diseases. We excluded girls who had <80% compliance with the treatment and those who participated in weight loss programs or took nutritional supplements or hormonal medications.

The number of participants calculated for each group was 66 at 90% power and α of 0.05 according to the effect of intervention on low concentration in the intervention (4.72 ± 1.05) and the control (5.29 ± 0.95) groups [10]. To allow for attrition, 73 participants for each group and collectively 146 girls in both groups were employed.

The 130 participants who met the inclusion criteria were randomly allotted to 2 groups: the vitamin D group (n = 64) had to take a vitamin D tablet of 2,000 IU (Schiff; made in the USA), and the placebo group (n = 66) received a placebo tablet every other day with lunch. The placebo (“Roshd” Pharmaceutical Incubation Center of Tehran University of Medical Sciences) contained maltodextrin and had a similar appearance to the vitamin D tablet. The intervention was administered for 12 weeks. The participants were asked not to alter their ordinary dietary intake and physical activity during the intervention.

The current study was approved by the Iranian Registry of Clinical Trials (registration No. IRCT201510092365N10), and signed informed consent and subject assent was acquired. This study followed the CONSORT guidelines [11], and details of the trial are presented in Figure 1.

Fig. 1.

The Consort flowchart.

Fig. 1.

The Consort flowchart.

Close modal

The participants of the study were allocated randomly by using a random table; for this, a person who did not contribute to the study protocol made the randomization list and allotted the participants to the intervention or control group. Fourteen vitamin D or placebo tablets were placed into unlabeled containers; the study leader labeled them with participant numbers and by using the randomization list. Three containers for each participant were provided for intervention during three 4-week intervals. Compliance with the intervention was assessed by pill counts. For this, all of the participants returned their 3 containers at the end of the each 4-week period.

At the beginning and at the end of the intervention, serum 25-(OH)-D, PMS symptoms, weight, height, dietary intakes, sun exposure, and physical activity variables were investigated. Blood samples were collected after 10 h of overnight fasting before and after the study, and serum was subjected to centrifugation at 800–1,000 rpm for 10 min; the serum samples were frozen and kept at –80°C. Serum 25-(OH)-D level was measured by ELISA (Microplate Reader MPR4 Plus, Hiperion) and EUROIMMUN kit.

We measured body weight to the nearest 0.1 kg (Beurer, Germany). Height was evaluated to the nearest 0.5 cm in standing posture without shoes. BMI was calculated as body weight (kg)/height squared (m2).

Dietary intakes were investigated with a 24-h food recall for 2 days (1 week day and 1 weekend day), and nutrient intakes were determined by using nutritionist 4 software. Physical activity level was evaluated by the Persian and short form of the International Physical Activity Questionnaire (IPAQ) and presented in MET-min/week [12]. Sun exposure was measured quantitatively with the questionnaire. A sunlight exposure score was obtained based on (a) how often and what time of day the participants were outside, (b) which proportions of the body were exposed as a percentage of total body surfaces, and (c) whether the participants used sun screen or not [13].

Assessment of PMS

The identification of PMS for each volunteer was confirmed in an interview and after selection of the subjects, and the validated Iranian version of the Premenstrual Symptoms Screening Tool (PSST) questionnaire [14], based on diagnostic criteria of the American College of Obstetrics and Gynecology, was completed. All subjects fulfilled the criteria for 3 successive months before entering the study. The girls should have 1 or more somatic or mood symptoms for 5 days before the beginning of the menstruation, in 3 previous cycles, which finished with the onset of menstruation.

Mood symptoms included depression, jitteriness, anxiety, dizziness, low concentration, and impaired social activity. Somatic symptoms included breast tenderness, bloating, headache, and edema. The symptoms should have improved in the first 4 days of menstruation and not begin until day 13 of the cycle.

Statistical analysis was performed with SPSS version 20. The Kolmogorov-Smirnov test was used to evaluate normality of data. Descriptive statistics were shown as means ± standard deviations. Differences between the 2 groups at baseline and at week 12 were measured with the independent t test. Comparison of non-normally distributed data was done by using the Wilcoxon signed-rank test and the Mann-Whitney U test. p < 0.05 was considered statistically significant.

Of 146 participants included in the study, 9 in the intervention group and 7 in the placebo group withdrew because of personal reasons or nonadherence to the intervention. Compliance with the intervention was about 90% in each group. There were no significant differences between the 2 groups regarding age, weight, height, BMI, physical activity, and serum 25(OH)-D at baseline (Table 1), and the participants of the 2 groups did not have any significant differences in the severity of the symptoms except for anxiety, weeping, and hypersomnia (Table 2). Moreover, none of the participants used sedatives during menstruation. The mean dietary intake of energy, carbohydrate, protein, total fat, fiber, vitamin D, vitamin E, and vitamin C was not significantly different between the 2 groups at baseline and after 12 weeks (Table 3). These dietary intake components did not change significantly within each group during the study (p > 0.05). This intervention was done in winter, and the participants mainly used sunscreen with SPF (Sun Protection Factor) >10; so in both the vitamin D and placebo groups, at baseline and also during the intervention, cutaneous synthesis of vitamin D was not substantial.

Table 1.

Characteristics of the participants in the vitamin D and placebo groups at baseline and after 12 weeksa

Characteristics of the participants in the vitamin D and placebo groups at baseline and after 12 weeksa
Characteristics of the participants in the vitamin D and placebo groups at baseline and after 12 weeksa
Table 2.

Comparison of the baseline and posttreatment values of the severity of PMS symptoms between the vitamin D and placebo groupsa

Comparison of the baseline and posttreatment values of the severity of PMS symptoms between the vitamin D and placebo groupsa
Comparison of the baseline and posttreatment values of the severity of PMS symptoms between the vitamin D and placebo groupsa
Table 3.

Dietary intakes of participants before and after 12 weeksa

Dietary intakes of participants before and after 12 weeksa
Dietary intakes of participants before and after 12 weeksa

Serum 25(OH)-D concentration reached 21.9 ± 7.9 versus 3.7 ± 4.3 ng/mL (p < 0.001), respectively, in the intervention group compared to the placebo group after 12 weeks (Table 1). Hence, serum 25(OH)-D levels were significantly elevated in the vitamin D group in comparison to the placebo group after 12 weeks. There was no significant difference between the 2 groups with regard to 14 symptoms of PMS after 12 weeks of intervention, even after adjustment for the baseline values of anxiety, weeping, and hypersomnia (for all symptoms, p > 0.05) (Table 2). However, in the vitamin D group, nervousness scores of 2.09 ± 0.90 at baseline reached 1.71 ± 0.74 (p < 0.001), job activity reduction scores of 1.46 ± 0.97 at baseline reached 1.12 ± 0.80 (p = 0.01), social activity reduction scores of 1.43 ± 0.85 at baseline reached 1.15 ± 0.76 (p = 0.01), fatigue scores of 1.95 ± 0.91 at baseline reached 1.45 ± 0.79 (p < 0.001), and physical symptoms scores of 1.98 ± 0.98 at baseline reached 1.60 ± 0.93 (p = 0.00) at the end of the intervention. These changes were statistically significant compared to baseline. However, these alterations did not reach significance compared with the placebo group (p > 0.05) (Table 2, 4).

Table 4.

Comparison of the baseline and posttreatment values of the severity of symptoms in the vitamin D and placebo groupsa

Comparison of the baseline and posttreatment values of the severity of symptoms in the vitamin D and placebo groupsa
Comparison of the baseline and posttreatment values of the severity of symptoms in the vitamin D and placebo groupsa

The aim of this study was to evaluate the effect of vitamin D supplementation in the treatment of PMS in young girls. Of 146 participants firstly included in the study, 9 in the intervention group and 7 in the placebo group withdrew because of private reasons or nonadherence to the intervention. In the present study, intake of 2,000 IU of vitamin D every other day for 12 weeks significantly increased serum 25(OH)-D levels in the vitamin D group compared to the placebo group. But significantly ameliorating the vitamin D condition in the intervention group did not result in significant differences in symptoms of PMS between the 2 groups. In this study, PMS was investigated according to 14 aspects, including nervousness, anxiety, weeping, depression, job activity reduction, home activity reduction, social activity reduction, low concentration, fatigue, bulimia, insomnia, hypersomnia, delirium, and physical symptoms. At the end of the intervention in the vitamin D group, the severity of nervousness, slump job activity, fatigue, and physical symptoms improved at the end of the intervention, and these changes were statistically significant compared to baseline.

A cross-sectional study [15] with the aim of investigating the prevalence of menstrual symptoms resulting from primary dysmenorrhea in female university students, and to survey a possible association with vitamin D and parathyroid hormone (PTH) concentrations, showed no difference in the levels of vitamin D, whether normal, insufficient, or deficient between participants with and those without premenstrual symptoms. Studies about vitamin D investigated mainly the effect of supplements or dietary intake on premenstrual symptoms, and a lower incidence of premenstrual symptoms has been demonstrated with a high vitamin D intake [16, 17]. However, a variation in vitamin D usage in women with and those without premenstrual symptoms demonstrated by Thys-Jacobs [18] in 2007 suggested that variations in the levels of calcium-controlling hormones all through the cycle are important in women with severe forms of PMS. Calcium as a micronutrient is directly associated with the severity of the symptoms of PMS [19, 20]. Vitamin D and PTH are key agents in calcium homeostasis [15]. Calcium and vitamin D may affect the development of PMS via their association with endogenous estrogens [21]. Unfortunately, in the current study, we did not evaluate calcium and PTH levels. In addition, PMS includes a wide variety of symptoms, and many of these symptoms are experienced by most menstruating women and may result from disorders other than PMS [22, 23].

In a study [24] with the aim of evaluating the effect of vitamin D supplementation on the treatment of primary dysmenorrhea with vitamin D deficiency, participants in the intervention group received 50,000 IU vitamin D and the control group received placebo weekly for 8 weeks. The results of this study showed that weekly oral vitamin D (50,000 IU) supplementation for 8 weeks in vitamin D-deficient women with primary dysmenorrhea improved pain intensity. In this study, after treatment, serum 25(OH)-D in the intervention group was elevated from a deficient to a sufficient level, while in our study, after treatment, serum 25(OH)-D in the intervention group increased from a deficient to an insufficient level and did not reach sufficient levels. This may demonstrate that higher levels of vitamin D may lead to more reduction in pain intensity. However, this needs to be established in future investigations. Another clinical trial with the aim of investigating the impact of vitamin D supplementation (50,000 IU, weekly, over 9 weeks) on dysmenorrhea and PMS in adolescents demonstrated that vitamin D supplementation was related to a reduction in the incidence of some symptoms of PMS, including backache, tendency to cry easily, and also decrement in pain severity of dysmenorrhea [25]. These results show that higher doses of vitamin D may lead to more improvement in PMS-related disorders.

In another study [1] with the aim of evaluating the effect of vitamin D administration (200,000 IU at first, followed by 25,000 IU every 2 weeks, for a 4-month period) on PMS-related mood disorders in adolescents, girls (15–21 years old) with PMS-related severe symptoms of the emotional and cognitive domains and low serum 25(OH)-D levels (≤10 ng/mL) were randomly allocated to intervention and placebo groups. The results of this study showed that in participants from the intervention group, 25(OH)-D reached a normal level. At the end of the intervention, scores of anxiety, irritability, weeping easily, and sadness decreased compared to baseline, and these changes were statistically significant. However, the frequency of adverse symptoms (nausea and constipation) was not different between the girls of the 2 groups. In this study, after supplementation, serum 25(OH)-D in the intervention group was elevated from a severely deficient to a sufficient level, while in our study, after treatment, serum 25(OH)-D in the intervention group increased from a deficient to an insufficient level and did not reach sufficient levels. This may show that higher levels of vitamin D may lead to more improvement in PMS-related mood disorders. Surprisingly, at the end of the study, some aspects of PMS, including nervousness, anxiety, weeping, low concentration, fatigue, and delirium, were improved in the placebo group, which probably resulted from an inculcation effect of the intervention, because these variables were subjective and all participants were informed about the aims of the intervention.

In the present study, the duration of treatment or the dose of vitamin D might have been insufficient to exert any significant changes in 25(OH)-D levels and, consequently, in PMS symptoms in the intervention compared to the placebo group.

This study has several important strengths. To our knowledge, the present study is the first randomized trial to evaluate the effect of vitamin D administration on 14 aspects of PMS. We assessed some dietary intakes and weight status that might have an effect on PMS.

There were some limitations in the current study; first, the duration of the treatment was short, and second, calcium and PTH levels were not measured. The long-term relationship between vitamin D intake and PMS symptoms and its association with calcium and PTH also needs to be evaluated.

It seems that 2,000 IU vitamin D consumption in vitamin D-deficient young girls with PMS every other day for 12 weeks had no significant impact on other PMS symptoms.

We thank the participants for their cooperation and participation in this study. This research is a part of the M.Sc. thesis in nutrition sciences, which was financially supported by the Vice Chancellor of Research, Iran University of Medical Sciences (Tehran, Iran).

This protocol, approved by the Medical Ethics Committee of Iran University of Medical Sciences, is in accordance with the Declaration of Helsinki. Each subject signed an informed consent form. This investigation was registered on the Iranian Registry of Clinical Trials (IRCT registration No. IRCT201510092365N10).

The authors declare that they have no competing interests.

This research was funded by Iran University of Medical Sciences.

R.A., B.A., and M.V. designed this study. B.A. drafted the manuscript. P.S. analyzed the data. M.V., P.S., and M.K. critically revised the manuscript. R.A. and B.A. participated in the conduction of the study. All authors read and approved the final manuscript.

All data generated or analyzed during this study are included in this published article.

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