Clinical Trials

Medical Studies on Melatonin – Clinical Trials

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In this category you will find the most relevant placebo-controlled clinical studies and reviews on melatonin.

The selection of the presented studies was made with the aim of reflecting the broad spectrum of different applications and implications of melatonin.

Medical Studies on Melatonin – Clinical Trials

Melatonin: From Pharmacokinetics to Clinical Use in Autism Spectrum Disorder

2021-02 Lalanne S, Fougerou-Leurent C, Anderson GM, Schroder CM, Nir T, Chokron S, Delorme R, Claustrat B, Bellissant E, Kermarrec S, Franco P, Denis L, Tordjman S

The role of melatonin has been extensively investigated in pathophysiological conditions, including autism spectrum disorder (ASD). Reduced melatonin secretion has been reported in ASD and led to many clinical trials using immediate-release and prolonged-release oral formulations of melatonin. However, melatonin’s effects in ASD and the choice of formulation type require further study.

Dietary Melatonin Therapy Alleviates the Lamina Cribrosa Damages in Patients With Mild Cognitive Impairments: A Double-Blinded, Randomized Controlled Study.

2020-05 Xu L, Yu H, Sun H, Hu B, Geng Y

Alzheimer's disease (AD) is a degenerative disease that is characterized by massive neuron devastations in the hippocampus and cortex. Mild cognitive impairment (MCI) is the transitory stage between normality and AD dementia. This study aimed to investigate the melatonin induced effects on the lamina cribrosa thickness (LCT) of patients with MCI.

The Effects of Melatonin Supplementation on Parameters of Mental Health, Glycemic Control, Markers of Cardiometabolic Risk, and Oxidative Stress in Diabetic Hemodialysis Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.

2020-05 Ostadmohammadi V, Soleimani A, Bahmani F, Aghadavod E, Ramezani R, Reiter RJ, Mansournia MA, Banikazemi Z, Soleimani M, Zaroudi M, Asemi Z

This study evaluated the effects of melatonin supplementation on parameters of mental health, glycemic control, markers of cardiometabolic risk, and oxidative stress in diabetic hemodialysis (HD) patients.

Effect of Nocturnal Melatonin Intake on Cellular Damage and Recovery From Repeated Sprint Performance During an Intensive Training Schedule.

2020-05 Farjallah MA, Ghattassi K, Ben Mahmoud L, Graja A, Boudaya M, Elleuch H, Jammoussi K, Sahnoun Z, Souissi N, Chtourou H, Hammouda O

An optimal recovery between training sessions is of similar if not greater importance as the training content and program of the training, itself. One of the most used strategies for improving recovery is the ingestion of supplements.

Clinical Impact of Melatonin on Breast Cancer Patients Undergoing Chemotherapy; Effects on Cognition, Sleep and Depressive Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial.

2020-04 Palmer ACS, Zortea M, Souza A, Santos V, Biazús JV, Torres ILS, Fregni F, Caumo W

This randomized, double-blinded, placebo-controlled trial tested the hypothesis that 20mg of melatonin before and during the first cycle of adjuvant chemotherapy for breast cancer (ACBC) reduced the side effects associated with cognitive impairment.

Antioxidant and Anti-Inflammatory Properties of Melatonin in Patients With Type 2 Diabetes Mellitus With Periodontal Disease Under Non-Surgical Periodontal Therapy: A Double-Blind, Placebo-Controlled Trial.

2020-03 Zare Javid A, Hosseini SA, Gholinezhad H, Moradi L, Haghighi-Zadeh MH, Bazyar H

The imbalance between pro-oxidant and antioxidant systems often leads to further oxidative damage in the pathogenesis of both diabetes and periodontal disease. This study aimed to investigate the antioxidant and anti-inflammatory properties of melatonin in type 2 diabetes mellitus (T2DM) patients with periodontal disease (PD) under non-surgical periodontal therapy (NSPT).

Melatonin a Promising Candidate for DNA Double-Stranded Breaks Reduction in Patients Undergoing Abdomen-Pelvis Computed Tomography Examinations.

2020-03 Eskandari A, Mahmoudzadeh A, Shirazi A, Esmaely F, Carnovale C, Cheki M

Cancer incidence is 24% greater in children and young adults exposed to Computed Tomography (CT) scans than those unexposed. Non-repair of ionizing radiation-induced DNA double-Strand Breaks (DSBs) can initiate carcinogenesis. In the present study, we aimed to investigate the radioprotective potential of melatonin against DSBs in peripheral blood lymphocytes of patients undergoing the abdomen-pelvis CT examinations.

Effectiveness of Complementary and Alternative Medicine Interventions for Sleep Quality in Adult Intensive Care Patients: A Systematic Review.

2020-03 Cooke M, Ritmala-Castrén M, Dwan T, Mitchell M

Pharmacological interventions for sleep (analgesic, sedative and hypnotic agents) can both disrupt and induce sleep and have many negative side effects within the intensive care population. The use of complementary and alternative medicine therapies to assist with sleep has been studied but given the variety of modalities and methodological limitations no reliable conclusions have been drawn.

Circadian rhythm and its association with birth and infant outcomes: research protocol of a prospective cohort study.

2020-02 Kaur S, Teoh AN, Shukri NHM, Shafie SR, Bustami NA, Takahashi M, Lim PJ, Shibata S

Circadian rhythm plays an important role as our internal body's clock that synchronizes behavior and physiology according to the external 24-h light-dark cycle. Past studies have associated disrupted circadian rhythm with higher risk of miscarriages, preterm birth and low birth weights. This paper described the protocol of a prospective cohort study which aims to determine the circadian rhythm in pregnant women, identify its association with maternal factors during pregnancy, gestational weight gain, birth and infant outcomes.

Effect of Melatonin Supplementation in Combination With Neoadjuvant Chemotherapy to miR-210 and CD44 Expression and Clinical Response Improvement in Locally Advanced Oral Squamous Cell Carcinoma: A Randomized Controlled Trial.

2020-02 Kartini D, Taher A, Panigoro SS, Setiabudy R, Jusman SW, Haryana SM, Abdullah M, Rustamadji P, Purwanto DJ, Sutandyo N, Suroyo I, Siregar BH, Maruli H, Sungkar S

Squamous cell carcinoma of the oral cavity (OSCC) is the sixth most common malignancy. Surgery is mainstay treatment for oral cancers. Surgery in locally advanced OSCC presents many challenges primarily because the head and neck have critical structures that can be damaged by tumor or treatment.

Influence of Dietary Sources of Melatonin on Sleep Quality: A Review.

2020-01 Pereira N, Naufel MF, Ribeiro EB, Tufik S, Hachul H

Sleep is an essential biological phenomenon, being a physiological and behavioral process necessary for quality of life. Melatonin is a circadian hormone produced at night by the pineal gland, regulated by the light/dark cycle, under the control of the suprachiasmatic nucleus. Melatonin is an indoleamine, synthesized from the essential amino acid tryptophan via serotonin. Melatonin is also found in plants, where it helps fight oxidative stress. To present a systematic review on the ability of food sources of melatonin to promote healthy sleep.

The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial.

2019-12 Madsen MT, Zahid JA, Hansen CH, Grummedal O, Hansen JR, Isbrand A, Andersen UO, Andersen LJ, Taskiran M, Simonsen E, Gögenur I

Depression following acute coronary syndrome is prevalent and associated with increased mortality and morbidity. Melatonin may function as a primary prophylactic antidepressant substance and alleviate depressive symptoms. The study was undertaken to determine if melatonin administered following an acute coronary syndrome (ACS) could prevent development of depression.

The Effects of Melatonin on the Descending Pain Inhibitory System and Neural Plasticity Markers in Breast Cancer Patients Receiving Chemotherapy: Randomized, Double-Blinded, Placebo-Controlled Trial.

2019-11 Palmer ACS, Souza A, Dos Santos VS, Cavalheiro JAC, Schuh F, Zucatto AE, Biazus JV, Torres ILDS, Fregni F, Caumo W

Adjuvant chemotherapy for breast cancer (ACBC) has been associated with fatigue, pain, depressive symptoms, and disturbed sleep. And, previous studies in non-cancer patients showed that melatonin could improve the descending pain modulatory system (DPMS).

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