The effect of soy nut consumption on inflammatory markers? nutritional status, blood and bone marrow cells count and chemotherapy complications in children with acute lymphoblastic leukemia (ALL)

The effect of soy nut consumption on inflammatory markers, nutritional status, blood and bone marrow cells count and chemotherapy complications in children with acute lymphoblastic leukemia (ALL): A randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016040212571N4

Enrollment

Registered

2017-04-15

Start date

2016-04-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Acute lymphoblastic leukaemia [ALL]. Acute lymphoblastic leukaemia [ALL]

Interventions

Intervention 1: Intervention group: 30 g/day unsalted roasted soybean powder. Intervention 2: control group: 30 g/day unsalted roasted cowpea powder.

Treatment - Other

Placebo

Intervention group: 30 g/day unsalted roasted soybean powder

control group: 30 g/day unsalted roasted cowpea powder

Eligibility

Sex/Gender

All

Age

3 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Participants aged between 3-15 years old who have Acute lymphoblastic leukemia (ALL) confirmed by an oncologist; being in the consolidation phase of treatment (maintenance phase) with regular chemotherapy; Both patient and his/her parent intend to participate in the study; Not being on a specific diet; Subjects who do not have any allergies to soy or cowpea will not be included. Exclusion criteria: Subjects with relapse of the disease complication; lack of consumption of more than 50% of intervention supplements by participants; Occurrence of allergy upon supplements consumption; Subjects or parents who intend to leave the study with any reason.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Red blood cells count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;White blood cells counts. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Platelets count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Lymphocytes count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Neutrophil count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Monocytes count. Timepoint: At baseline and every month up to three months. Method of measurement: by complete blood count.;Blood Eosinophils count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood hemoglobin levels. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count (CBC).;Bone marrow blast percentage. Timepoint: At baseline and every month up to three months. Method of measurement: based on bone marrow samples.;Nausea. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS).;Vomiting. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Pain. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Fatigue. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Depression. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Anxiety. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS	—

Measure

Time frame

Red blood cells count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;White blood cells counts. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Platelets count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Lymphocytes count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Neutrophil count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood Monocytes count. Timepoint: At baseline and every month up to three months. Method of measurement: by complete blood count.;Blood Eosinophils count. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count.;Blood hemoglobin levels. Timepoint: At baseline and every month up to three months. Method of measurement: Complete blood count (CBC).;Bone marrow blast percentage. Timepoint: At baseline and every month up to three months. Method of measurement: based on bone marrow samples.;Nausea. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS).;Vomiting. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Pain. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Fatigue. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Depression. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS ).;Anxiety. Timepoint: At baseline and every month up to three months. Method of measurement: The Edmoton Symptom Assessment System (ESAS

—

Secondary

Measure	Time frame
Waist circunfrences. Timepoint: at baseline and every month up to three months. Method of measurement: Based on the standard protocol using tape measure.;Physical activity. Timepoint: at baseline and every month up to three months. Method of measurement: Based on the standard protocol and physical activity record.;Weight. Timepoint: at baseline and every month up to three months. Method of measurement: by digital scale.;Energy intake. Timepoint: at baseline and every month up to three months. Method of measurement: Using a three day dietary record.;Body mass index(BMI). Timepoint: at baseline and every month up to three months. Method of measurement: Weight ( in kilogram) divided by height (in meter) squared.	—

Measure

Time frame

Waist circunfrences. Timepoint: at baseline and every month up to three months. Method of measurement: Based on the standard protocol using tape measure.;Physical activity. Timepoint: at baseline and every month up to three months. Method of measurement: Based on the standard protocol and physical activity record.;Weight. Timepoint: at baseline and every month up to three months. Method of measurement: by digital scale.;Energy intake. Timepoint: at baseline and every month up to three months. Method of measurement: Using a three day dietary record.;Body mass index(BMI). Timepoint: at baseline and every month up to three months. Method of measurement: Weight ( in kilogram) divided by height (in meter) squared.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarges Ramezani

Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica

n.ramezani171@yahoo.com+98 35 3820 9100

Outcome results

None listed

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