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IRCT20121216011763N38 IRCT 2019-10-01 Esfahan University of Medical Sciences Dietary approach to stop hypertension (DASH) diet in migraine The effects of DASH (Dietary approach to stop hypertension) diet on severity, frequency, duration of headache and markers of oxidative stress in migraine patients 2019-11-21 anticipated 100 Complete https://irct.ir/trial/42284 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random number table. N/A Migraine. Intervention 1: Intervention group: Intervention group will receive DASH diet for 3 months. DASH diet have been designed to be included high levels of fruits, vegetables, whole grains and low fat dairy. In order to examine the adherence of participants to diet, serum levels of vitamin C have been assessed. Also, all of the assessment have been conducted at baseline and end of study. Intervention 2: Control group: The control group will receive a 3-month control diet including healthy dietary advice. Healthy dietary recommendation includes healthy advises based on food guide pyramid. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: En How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Gholamreza Askari
Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Arman Arab
Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8317745181 +98 31 4525 1696 arman4369@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who agree to participate in the study Diagnosis of migraine by a neurologist according to ICHD-3 Aged between 20 to 50 years old Body mass index between 18.5-30 kg/m2 20 years 50 years Female Men with migraine Migraine with aura Diagnosis of other disease such as cardiovascular disease, hypertension, diabetes, liver disease, kidney disease, thyroid disorders, malignancies and other neurological problem Pregnancy and lactation G43.0 Migraine without aura Treatment - Other Placebo Intervention group: Intervention group will receive DASH diet for 3 months. DASH diet have been designed to be included high levels of fruits, vegetables, whole grains and low fat dairy. In order to examine the adherence of participants to diet, serum levels of vitamin C have been assessed. Also, all of the assessment have been conducted at baseline and end of study Control group: The control group will receive a 3-month control diet including healthy dietary advice. Healthy dietary recommendation includes healthy advises based on food guide pyramid. Migraine severity. Timepoint: At baseline and after 12 weeks. Method of measurement: Visual analogue scale. Migraine frequency. Timepoint: At baseline and after 12 weeks. Method of measurement: Clinical examination. Migraine duration. Timepoint: At baseline and after 12 weeks. Method of measurement: Clinical examination. Headache impact test. Timepoint: At baseline and after 12 weeks. Method of measurement: HIT questionnaire. Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Serum vitamin C. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Total oxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Serum glutathion. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Blood pressure. Timepoint: At baseline and after 12 weeks. Method of measurement: Sphygmomonometer. Weight. Timepoint: At baseline and after 12 weeks. Method of measurement: Digital scale. Esfahan University of Medical Sciences Approved 2019-09-14 Ethics committee of Isfahan University of Medical Sciences Hezarjarib street Isfahan Isfehan Iran (Islamic Republic of)