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IRCT20231029059889N1 IRCT 2023-12-07 Mashhad University of Medical Sciences The effect of nanomicelle curcumin in children with Crohn's disease Investigating the effect of Nanomicelle curcumin compared to placebo on nutritional and paraclinical findings in children with Crohn's diseases: a triple-blind randomized controlled clinical trial. 2023-12-26 anticipated 60 Complete https://irct.ir/trial/73750 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization method and description of each method: block; Randomization Unit: Individual; Randomization tool: Sealed envelope, block randomization is done in order to balance the number of samples allocated to each of the study groups. For this purpose, online randomization (https://www.sealedenvelope.com) is used. The number and characteristics of the participants are entered in the specified location and people are randomly assigned to one of the intervention and placebo groups, Blinding description: In this triple-blind study, the participants, the main researcher, the doctor, the supervisors, the people responsible for collecting the data, the people who evaluate the outcome and also the data analyst, compared to the fact that each person participating in the study in the main intervention group (receiving nanomicelle curcumin supplement) or placebo (without nanomicelle curcumin) are unknown. For blinding, curcumin and placebo nanomicelle capsules will be similar in appearance, packaging and labeling. The packaging and coding process of the capsules will be done by the manufacturer (Nano Sina). 3 Children's Crohn's disease. Intervention 1: Intervention group: weight gain diet (500 kcal more than daily requirement) and two nanomicelle curcumin supplements (containing 40 mg of nanomicelle curcumin manufactured by Nanosina) are prescribed to the participants for 12 weeks. Intervention 2: Control group: receiving weight gain diet (500 kcal more than daily requirement) and placebo (the same amount and form of nanomicelle curcumin supplements manufactured by Nanosina Company), prescribed twice a day for 12 weeks. Yes - There is a plan to make this available What will be shared: Individually nonidentifiable data of participants will be shared in this study. also, the protocol, results, and statistical analysis of the study will be published in the relevant articles. When: Access to data begins 6 months after publication of results. To whom: The unidentifiable personal data of the participants will be made available to other researchers at academic institutions. Conditions: The unidentifiable personal data of the participants can only be used for research. Where to obtain: Individually nonidentifiable information of participants can be obtained by sending an email to Dr. Saeedeh Talebi (talebis@mums.ac.ir) How to obtain: Other researchers in academic institutions can send their requests by email to Dr. Saeedeh Talebi. The data will be sent to them after consulting and approving the research team. Comments:
public Mehrara Hashempour
Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 Hashempourm4012@mums.ac.ir Mashhad University of Medical Sciences scientific Saeedeh Talebi
No. 2.12, Taleghani 7., Ahmad Abad Street
Mashhad Iran (Islamic Republic of) 9176756436 +98 51 3842 0718 talebis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children 8 to 18 years old with Crohn's disease Mild to moderate disease severity based on Crohn's Disease Activity Index (CDAI) Interested in participating in the project and willing to follow the study protocol Informed consent has been obtained from the patients 8 years 18 years Both Using anticoagulants such as warfarin or antiplatelet Pregnancy and breastfeeding K50 Crohn's disease [regional enteritis] Treatment - Other Placebo Intervention group: weight gain diet (500 kcal more than daily requirement) and two nanomicelle curcumin supplements (containing 40 mg of nanomicelle curcumin manufactured by Nanosina) are prescribed to the participants for 12 weeks. Control group: receiving weight gain diet (500 kcal more than daily requirement) and placebo (the same amount and form of nanomicelle curcumin supplements manufactured by Nanosina Company), prescribed twice a day for 12 weeks. Body weight. Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement consumption. Method of measurement: Scales. Height. Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement consumption. Method of measurement: tape measure. Serum albumin. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement consumption. Method of measurement: Biochemical analysis of blood sample. Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: Formula (weight/height squared). Inflammation status (C-reactive protein). Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: Biochemical analysis of blood sample. Oxidative stress status(Interleukin 10). Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: ELISA. Body composition (fat mass, fat-free mass, lean body mass, skeletal muscle index, total body water content, basal metabolic rate). Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement. Method of measurement: Bioelectric Impedance Analysis (BIA) device. Dietary intake. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: 3-day 24-hour recall. Quality of Life. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the supplement. Method of measurement: Quality of life questionnaire for Crohn's patients. Mashhad University of Medical Sciences Approved 2023-11-14 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences Nutrition Department, School of Medicine, East door of Ferdowsi University, Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)