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IRCT20191014045100N1 IRCT 2020-02-18 Oroumia University of Medical Sciences Effect of supplementation on the treatment of migraine headaches Assessing the effect of zinc supplementation on lipid profile, hs-CRP, the frequency of migraine attacks and it`s duration and severity in adult women 2019-03-21 anticipated 60 Complete https://irct.ir/trial/44892 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the study, participants were randomly divided into two groups of 30 intervention and placebo with 1: 1 allocation ratio. Random block method was used for this purpose and the random numbers required for this method were generated using RAS software. Random-sized blocks of 4 and 6 were used to keep the study blind. Random numbers were generated by the project statistical consultant, Blinding description: Participants and either the researchers or the evaluators of the outcome were unaware of the allocation of study groups. 3 Migraine. Intervention 1: Intervention group: Zinc Gluconate tablets, 15 mg, daily, orally for 12 weeks. Intervention 2: Intervention group: Placebo tablets, 15 mg, daily, orally for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because of the confidentiality of study participants' information
public Rasoul Zarrin
Urmia St., Imam Reza Street, 12 meters south of No. 56
Urmia Iran (Islamic Republic of) 6257757168 +98 44 3346 9935 rasoul.zarrin@uqconnect.edu.au Oroumia University of Medical Sciences scientific Rasoul Zarrin
Urmia St., Imam Reza Street, 12 meters south of No. 56
Urmia Iran (Islamic Republic of) 6257757168 +98 44 3346 9935 rasoul.zarrin@uqconnect.edu.au Oroumia University of Medical Sciences Iran (Islamic Republic of) Age range 18-55 years female Resident of Urmia Having episodic or chronic migraines Interested in collaborating in the study with a 3-month intervention 18 years 55 years Female Use of any supplement or multivitamin - mineral in the last 3 months Pregnancy Breastfeeding smoking History of serious head trauma or head and neck surgery in the past 2 years A history of vasculitis Malignancies AIDS History of diabetes History of stroke and coronary artery disease Cardiovascular disease Asthma Rheumatoid Arthritis Kidney or liver failure kidney stone Use of drugs that decrease lipid profile (total cholesterol, TG, LDL-C) Taking non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen (for more than 15 days per month in the last 3 months) History of mental disorders such as depression blood pressure Digestive diseases 21. Lupus G43 Migraine Treatment - Drugs Placebo Intervention group: Zinc Gluconate tablets, 15 mg, daily, orally for 12 weeks Intervention group: Placebo tablets, 15 mg, daily, orally for 12 weeks Frequency of migraine attacks. Timepoint: At baseline (before intervention) and 30, 60, and 90 days after starting zinc gluconate supplementation. Method of measurement: Monthly Notepad. The severity of migraine attacks. Timepoint: At baseline (before intervention) and 30, 60 and 90 days after zinc gluconate supplementation. Method of measurement: Pain severity questionnaire NRS (Numeric Rating Scale). The period of migraine attacks. Timepoint: At baseline (before intervention) and 30, 60 and 90 days after zinc gluconate supplementation. Method of measurement: Monthly Notepad. Serum level of zinc. Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: dialab kit of zinc. Serum cholesterol level. Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: pars azmun kit. Serum triglyceride levels. Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: pars azmun kit. Serum level of Low Density Lipoprotein (LDL). Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: pars azmun kit. Serum level of High Density Lipoprotein (HDL). Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: pars azmun kit. Serum level of high sensitivity C-Reactive Protein (hs-CRP). Timepoint: At baseline (before intervention) and 90 days after zinc gluconate supplementation. Method of measurement: pars azmun kit. Oroumia University of Medical Sciences Approved 2019-04-28 Ethics committee of Urmia University of Medical Sciences Urmia, Apadana intersection, Zaker street, Bostan dormitory urmia West Azarbaijan Iran (Islamic Republic of)