Alterations in CD4+ T Cell Cytokines Profile in Female Patients with Hashimoto's Thyroiditis Following Vitamin D Supplementation: A Double-blind, Randomized Clinical Trial.

BACKGROUND: Hashimoto's thyroiditis (HT) is an autoimmune disease characterized by the destruction of thyroid cells through immune processes involving T helper (Th)1 cytokines. This clinical trial investigates the impact of vitamin D supplementation on serum cytokine levels and gene expression in CD4+ T cells from HT patients, aiming to understand its effects on Th-1, Th-2, Th-17, and regulatory T (Treg) cell-associated factors. METHODS: Female patients were randomly assigned in a double-blind design to either a vitamin D-supplemented group, which received cholecalciferol [1, 25(OH)2D3] at a dose of 50,000 IU, or the placebo group, which received a weekly placebo for a duration of three months. Serum cytokine levels were assessed using enzyme-linked immunosorbent assay (ELISA), while genes' expression levels were measured using real-time PCR. RESULTS: Serum 25-hydroxyvitamin D and levels exhibited a significant increase following vitamin D supplementation, in comparison to the placebo group. Additionally, the vitamin D supplementation resulted in a significant elevation of serum calcium (Ca) levels compared to baseline. In the vitamin D group, there was a significant decrease in both serum levels and expression of the interleukin (IL)-17 gene when compared to baseline, although no statistical difference was observed between the placebo and vitamin D groups. The gene expression of transforming growth factor-beta (TGFß) was significantly increased in the vitamin D group compared to baseline, with no significant difference between the two study groups. Vitamin D treatment had no effect on serum levels of interferon-gamma (IFNϒ) and IL-4. While the gene expression of IL-4 in the vitamin D group did not exhibit a statistically significant increase, the level of GATA3 transcription factor increased significantly when compared to the placebo group. The expression of IFNϒ and transcription factors, T-bet, RORc, and forkhead box protein 3 (FOXP3) in genes did not show significant changes following vitamin D supplementation. CONCLUSION: The findings suggest that vitamin D supplementation may hold potential benefits for autoimmune diseases, such as HT. However, further longitudinal clinical trials are necessary to gain a more comprehensive understanding of the specific effects of vitamin D on HT. CLINICAL TRIAL REGISTRATION NUMBER: IRCT2016110130644N1.

Effectiveness of Echium amoenum on premenstrual syndrome: a randomized, double-blind, controlled trial.

BACKGROUND: The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo. METHODS: The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups. RESULTS: Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively. CONCLUSION: Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome. TRIAL REGISTRATION: IRCT2015110822779N3 ; Registration date: 2015-11-27.

Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial.

Background Premenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS. Methods The present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used. Results Eventually, sixty-seven 18-35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively. Conclusion Results of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.

Can Supplementation with Vitamin D Modify Thyroid Autoantibodies (Anti-TPO Ab, Anti-Tg Ab) and Thyroid Profile (T3, T4, TSH) in Hashimoto's Thyroiditis? A Double Blind, Randomized Clinical Trial.

Hashimoto's thyroiditis (HT) is the most prevalent autoimmune disorder characterized by the destruction of thyroid cells caused by leukocytes and antibody-mediated immune processes accompanied by hypothyroidism. In recent years, evidence has emerged pointing to various roles for vitamin D, including, proliferation and differentiation of normal and cancer cells, cardiovascular function, and immunomodulation. Vitamin D deficiency has been especially demonstrated in HT patients. The aim of this study was to investigate the effect of vitamin D on circulating thyroid autoantibodies and thyroid hormones profile (T4, T3, and TSH) in females with HT. Forty-two women with HT disease were enrolled in this randomized clinical trial study and divided into vitamin D and placebo groups. Patients in the vitamin D and placebo groups received 50 000 IU vitamin D and placebo pearls, weekly for 3 months, respectively. The serum levels of 25-hydroxy vitamin D [25(OH) D], Ca++ion, anti-thyroperoxidase antibody (anti-TPO Ab), anti-thyroglobulin antibody (anti-Tg Ab), T4, T3, and TSH were measured at the baseline and at the end of the study using enzyme-linked immunosorbent assays. The results of this study showed a significant reduction of anti-Tg Ab and TSH hormone in the Vitamin D group compared to the start of the study; however, there was a no significant reduction of anti-TPO Ab in the Vitamin D group compared to the placebo group (p=0.08). No significant changes were observed in the serum levels of T3 and T4 hormones. Therefore, vitamin D supplementation can be helpful for alleviation of the disease activity in HT patients; however, further well controlled, large, longitudinal studies are needed to determine whether it can be introduced in clinical practice.

Effect of Bedtime Melatonin Administration in Patients with Type 2 Diabetes: A Triple-Blind, Placebo-Controlled, Randomized Trial.

Melatonin is widely available as over the counter product. Despite promising effects of melatonin supplementation on glycemic control, there is a significant heterogeneity between studies. The current study aimed at determining the effect of melatonin on fasting blood glucose (FBG), insulin resistance/sensitivity indices, glycosylated hemoglobin A1c (HbA1c), and high sensitivity C-reactive protein (hs-CRP) among type 2 diabetes mellitus (T2D) population during 8 weeks in a randomized, triple-blind, placebo-controlled trial. Thirty four subjects with the mean age ± standard deviation of 57.74 ± 8.57 years and 36 subjects with the mean age of 57.61 ± 9.11 years were allocated to 6 mg nightly melatonin and placebo groups, respectively. Melatonin and placebo groups were matched by age, gender, body mass index, and duration of diabetes. Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%, P=0.042). After trial completion, the increase of serum levels of melatonin was greater in the intervention than the placebo group (3.38 ± 1.33 vs 0.94 ± 1.28 ng/L, P=0.192). Moreover, compared to placebo group, among melatonin users, homeostasis model assessment of insulin resistance (HOMA1-IR) tended to be unfavorable at the end of follow-up [-0.51 (-1.76-0.81) vs. 0.28 (-1.24-1.74), P=0.20]; the similar trend was also shown for insulin sensitivity index (HOMA1-S) [2.33 (-3.59-12.46) vs. -2.33 (-10.61-9.16), P=0.148]. No differences were observed in FBG, HbA1C, and hs-CRP changes between the trial groups. The current study did not support the improving effect of melatonin on glucose homeostasis.

The Impact of Iodine Status on the Recall Rate of the Screening Program for Congenital Hypothyroidism: Findings from Two National Studies in Iran.

Back ground: Iodine deficiency is one of the important factors in increasing the recall rate in congenital hypothyroidism (CH) screening programs. The present study assessed whether the iodine status of the general population may predict the recall rate or vice versa. METHODS: In the current national study, among 1,382,229 live births delivered between March 2010 and March 2011, 1,288,237 neonates were screened for detecting CH by TSH (thyroid stimulating hormone) measurement via heel prick sampling. Simultaneously, a total of 11,280 school-aged children, aged 7-8 years, were selected using random multi-cluster sampling for measurement of urinary iodine. RESULTS: A negative correlation was found between median urinary iodine (MUI) and the recall rate (r = -0.33, p = 0.03). No correlation was found between MUIC (median urinary iodine concentration) and the incidence rate of CH. Linear regression analysis showed a 0.1% increase in the recall rate for a one unit decrease in MUIC (ß = -0.11, 95% CI: -0.2, -0.1, p = 0.03). MUIC, at a cut-off point of 144.7 µg/L, was predictive for a recall rate < 3% (p = 0.05). CONCLUSION: Frequencies of TSH ≥ 5 mU/L may be a more sensitive indicator for iodine status during pregnancy rather than in the general population. As higher recall rates reflect inadequate iodine nutrition, sufficient iodine supplementation is needed to reduce the recall rate in such communities.