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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231029059889N1

Enrollment

Registered

2023-12-07

Start date

2023-12-26

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children's Crohn's disease. Crohn's disease [regional enteritis]

Interventions

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)

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Using anticoagulants such as warfarin or antiplatelet Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
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).;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.	—

Measure

Time frame

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).;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrara Hashempour

Mashhad University of Medical Sciences

Hashempourm4012@mums.ac.ir+98 51 3882 7034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026