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IRCT20181020041387N2 IRCT 2024-06-28 Yazd University of Medical Sciences The effects of Synbiotic on minerals The effects of Synbiotic supplementation on blood and milk minerals and trace elements of lactating mothers 2018-04-04 anticipated 80 Complete https://irct.ir/trial/66152 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the group allocation is performed through permuted block randomization at an assignment ratio of 1:1. patients were randomly divided into 2 groups: intervention group (as synbiotic supplement group) and control group (as placebo group) (named groups A and B). Group assignment was done through closed envelopes. Six of the four combinations of intervention and placebo groups A and B were determined AABB ABAB ABBA BBAA BABA BAAB (With block random assignment using a random number table). Block size was 4. For allocation concealment, the randomisation codes were kept in opaque, sealed, sequentially numbered envelopes, Blinding description: Patients who enrolled in the study based on the randomization list received sealed envelopes from the secretory ward and presented them to the researcher. The researcher administered the drugs labelled as A or B according to the codes within the envelopes. Both the drugs (synbiotic supplement and the placebo capsules) were identical in appearance, shape, color, and packaging, with the only difference being the manufacturer-assigned codes. In this study, the participants, healthcare providers, the researcher doctor who provides the drug to the patients and is responsible for the follow-up of the patient-, data collectors, data and safety monitoring board and outcome assessors are not aware of the assigned groups. After the completion of the study and analysis by the statistician, the codes are determined by the manufacturing company. 3 Lactating mothers. Intervention 1: Intervention group: Lactating mothers took one capsule of LactoFem including 109 CFU of probiotics (Lactobacillus fermentum, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus gasseri, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus casei), and prebiotic Fructooligosaccharides (FOS) manufactured by Zist Takhmir Company daily for 30 days. Intervention 2: Control group: Lactating mothers took one placebo capsule that was similar in shape, tase and color with Lactofem capsules, manufactured by Zist Takhmir company, daily for 30 days. Yes - There is a plan to make this available What will be shared: Demographic data and data of primary outcomes When: Up to six months after publication of the article To whom: Faculty members and students Conditions: Request through academic email Where to obtain: Email to dr.modarres@gmail.com How to obtain: Email to dr.modarres@gmail.com Comments:
public Seyedeh Zalfa Modarresi
Shahid Sadoughi Hospital, Shahid Ghandi Blvd., Yazd, Iran
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3822 4000 dr.modarres@gmail.com Yazd University of Medical Sciences scientific Majid Aflatoonian
Children Growth Disorder Research Center, Shahid Sadoughi Hospital, Shahid Ghandi street
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3183 3502 aflatoonianm@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Mothers who have 1-2 months old infants Mothers who have exclusively breast fed infants Mothers aged 18-35 years old. Mothers who have Infants born in more than 36 weeks of gestational age Mothers whom their infants birth weight was more than 2500 gram. 18 years 35 years Female Mothers with chronic disorders Taking Antibiotics 2 weeks prior to the study by mothers. Taking any other multivitamin and mineral supplements except that is administered by the health team for all lactating mothers. History of hospitalization in infants Z39.1 Encounter for care and examination of lactating mother Prevention Placebo Intervention group: Lactating mothers took one capsule of LactoFem including 109 CFU of probiotics (Lactobacillus fermentum, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus gasseri, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus casei), and prebiotic Fructooligosaccharides (FOS) manufactured by Zist Takhmir Company daily for 30 days. Control group: Lactating mothers took one placebo capsule that was similar in shape, tase and color with Lactofem capsules, manufactured by Zist Takhmir company, daily for 30 days. Plasma Calcium (Ca) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Calcium (Ca) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Magnesium (Mg) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Magnesium (Mg) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Iron (Fe) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Iron (Fe) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Copper (Cu) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Copper (Cu) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Manganese (Mn) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Manganese (Mn) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Milk Zinc (Zn) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Zinc (Zn) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Plasma Aluminium (Al) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry. Infant weight for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6 and 12 months old. Method of measurement: Scale, weight for age z-score chart. Infant height for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6 and 12 months old. Method of measurement: Meter, Height for age z-score chart. Infant head circumference for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6, 12 and 36 months old. Method of measurement: Meter, head circumference for age z-score chart. Infant wheezing episodes. Timepoint: At the age of 12 months. Method of measurement: Parents statement. Infant Hospitalization. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement. Bronchodilator inhaler usage. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement. Infants' taking antibiotics. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement. Infants' constipation. Timepoint: before and after intervention. Method of measurement: Parents' statement. Mothers' constipation. Timepoint: At the base of intervention, a month after intervention. Method of measurement: Mothers' statement. Infants' Eczema. Timepoint: At the base of intervention, a month after intervention. Method of measurement: Mothers' statement. Yazd University of Medical Sciences Approved 2017-11-29 Research ethics committees of school of medicine- Shahid Sadoughi University of Medical Sciences School of Medicine, Shohadaye Gomnam BLVD., Alem Square, Safaeiyeh, Yazd, Iran. Yazd Yazd Iran (Islamic Republic of)