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IRCT20140413017254N6 IRCT 2018-11-04 Tehran University of Medical Sciences Comparison the effects of different amounts of vitamin D supplementation on calcidiol, Anthropocentric status and body composition in lactation women with body mass index 25 and higher and their infants growth and frequency of visiting a doctor. Comparison the effects of different amounts of vitamin D supplementation on calcidiol, Anthropocentric status and body composition in lactation women with body mass index 25 and higher and their infants growth and frequency of visiting a doctor. 2018-11-06 anticipated 90 Complete https://irct.ir/trial/34647 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization method: Randomize permuted block randomization blocks Random unit: Individual Randomized layers for stratified randomization: for age (under 30 and over 30) and body mass index (below30 and higher than 30) Randomization Tool: random letters table, Blinding description: How to blind the study: Three types of supplements and placebo will be provided with the same shape, color and size. A person who is not involved in the research team will be required to code for a variety of supplements, such as for the subjects and the researchers not be identified. At the end of the data collection, the codes of the supplements will be opened. N/A deficiency of vitamin D in lactating women. Intervention 1: Intervention group: Group 1: Vitamin D supplementation of 2000, IU/d in the form of micro nano capsules from the Nano hayat Pharmacy Company. A daily supplement of 2000 IU/d will be taken as a lunch capsule and a placebo with dinner. Intervention 2: Intervention group: The second group: two vitamins supplementation, 2000 IU/d, in the form of micro nano capsules from the nano-pharmaceutical company. A daily supplement of 2000IU/d will be consumed as a lunch capsule and a supplement of 2000IU/d. Intervention 3: The control group contains of 2000 IU/d vitamin D placebo in the form of micro nano from nano hayat pharmacy company. A daily dose of 2000 IU/d placebo will be taken as a lunch capsule and one placebo with dinner. 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 at first the study is all the sample that no data is disseminated
public zohre gerveieeha
School of Nutrition, Tehran University Medical Sciences, Naderi St., Keshavar Blvd., Tehran
qazvin Iran (Islamic Republic of) 1439957181 +98 28 3369 0457 z.gerveiee1989@gmail.com Tehran University of Medical Sciences scientific Gity Sotodeh
School of Nutrition, Tehran University of Medical Sciences, Naderi St., Keshavar Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 2188955698 +98 21 8895 5742 gsotodeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 20-49 Mother expresses feeding their infant Maternal delivery (between weeks 37 and 42) Body Mass Index (BMI): 25-39.9 20 years 49 years Female Detected diseases such as cancer, digestive diseases, diabetes, high blood pressure, liver, kidney, autoimmune diseases, inflammation, thyroid Changing in diet over the past 3 months Regular supplementation of vitamin D (at least once a week or supplementing 50,000 units per month) or multivitamins (at least once a week) Smoking or any smoking, even once a week Treatment - Other Treatment - Other Treatment - Other Intervention group: Group 1: Vitamin D supplementation of 2000, IU/d in the form of micro nano capsules from the Nano hayat Pharmacy Company. A daily supplement of 2000 IU/d will be taken as a lunch capsule and a placebo with dinner. Intervention group: The second group: two vitamins supplementation, 2000 IU/d, in the form of micro nano capsules from the nano-pharmaceutical company. A daily supplement of 2000IU/d will be consumed as a lunch capsule and a supplement of 2000IU/d. The control group contains of 2000 IU/d vitamin D placebo in the form of micro nano from nano hayat pharmacy company. A daily dose of 2000 IU/d placebo will be taken as a lunch capsule and one placebo with dinner. Calcidiol. Timepoint: Before the intervention, After the intervention. Method of measurement: KIT. PTH. Timepoint: Before the intervention, After the intervention. Method of measurement: KIT. Calcium. Timepoint: Before the intervention, After the intervention. Method of measurement: KIT. Phosphore. Timepoint: Before the intervention, After the intervention. Method of measurement: KIT. Waist Circumference. Timepoint: Before the intervention, After the intervention. Method of measurement: meter-. Height. Timepoint: Before the intervention, After the intervention. Method of measurement: meter. Weight. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Fat mass. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Fat free mass. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Body fat percentages. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Fat mass index. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Body mass index. Timepoint: Before the intervention, After the intervention. Method of measurement: body impedance analysis Inbody270. Relative fat mass. Timepoint: Before the intervention, After the intervention. Method of measurement: RFM index for women calculated as 76 − (20 height × WC in meters). Assessment of Neonatal Growth(height, head circumference and weight). Timepoint: Before the intervention, After the intervention. Method of measurement: Data recorded in the case before the intervention and measurements of height, head circumference by meter and weight by scale at the end of the intervention. Frequency of visiting a doctor. Timepoint: Before the intervention, After the intervention. Method of measurement: doctor. Tehran University of Medical Sciences Approved 2018-10-01 Ethics committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Ghods st., Keshavarz Blv., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)