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IRCT20210109049971N1 IRCT 2021-01-18 Shiraz University of Medical Sciences Albumin protein and malnutrition indices in primary school children Evaluating the effect of albumin consumption on malnutrition indices in primary school children with mild to moderate underweight 2020-06-30 anticipated 60 Complete https://irct.ir/trial/53563 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will randomly be allocated in a 1:1 ratio, to intervention and control groups. Randomization will be conducted by random allocation software to allocate patients using blocked randomization with a fixed block size of 4. Randomization will be done by an investigator who had no clinical involvement in the trial. Furthermore, other procedures including enrollment, sequence generation, allocation concealment, and randomization process will all be performed by the principal investigators, Blinding description: In order to blind patients, the interventions in both groups will identical in appearance and color. The interventions will be coded differently in each group to blind the investigator. 3 Primary school children with mild to moderate underweight. Intervention 1: Intervention group: Participants in this group receive 200 cc cow's milk with 10gr albumin powder per day for 12 weeks. Intervention 2: Control group: Participants in this group receive 200 cc cow's milk with 10gr cornstarch powder per day for 12 weeks. Yes - There is a plan to make this available What will be shared: Total data after unidentifiable individuals by the researcher is shareable When: The access period starts 6 months after publishing the results. To whom: It will be available only to researchers working in academic and scientific institutions Conditions: In order to investigate and perform further analyzes Where to obtain: Siavash Babajafari 09177871387 How to obtain: After sending the request and reviewing the request by the coresponding author, the data will be provided to you Comments:
public Siavash Babajafari
Razi Blvd
Shiraz Iran (Islamic Republic of) 7193635889 +98 71 3612 2283 jafaris@sums.ac.ir Shiraz University of Medical Sciences scientific Hajar Davarpanah
Razi Blvd
Shiraz Iran (Islamic Republic of) 7193635889 +98 71 3612 2283 davarpanah.nut65@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Elementary students Lack of underlying disease affecting student development such as diabetes, hypothyroidism, liver and kidney problems Do not take dietary supplements or do not follow a special diet for at least 6 months before the study Mild to moderate underweight 7 years 13 years Both Treatment - Other Placebo Intervention group: Participants in this group receive 200 cc cow's milk with 10gr albumin powder per day for 12 weeks Control group: Participants in this group receive 200 cc cow's milk with 10gr cornstarch powder per day for 12 weeks Z-Score Body mass index-for-age. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Anthropometric indicators through scales and tape meters; Body composition with BIA device. Shiraz University of Medical Sciences Approved 2020-06-29 Ethics committee of Shiraz University of Medical Sciences Zand Blvd Shiraz Fars Iran (Islamic Republic of)