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Dietary Supplement

Ready-to-use therapeutic food + Hydroxyurea for Severe Acute Malnutrition in Sickle Cell Anemia

Phase 2

Waitlist Available

Led By Michael DeBaun

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up feasibility over 12-week period [time frame: 3 months]

Awards & highlights

Study Summary

This trial is to see if families of children with sickle cell anemia over 5 years old will participate in a 12-week program to improve their nutrition, and to see if it is safe.

Eligible Conditions

Sickle Cell Anemia
Malnutrition

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ feasibility over 12-week period [time frame: 3 months]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~feasibility over 12-week period [time frame: 3 months]

This trial's timeline: 3 weeks for screening, Varies for treatment, and feasibility over 12-week period [time frame: 3 months] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fetal Hemoglobin Level Percentage

Change in Mean Corpuscular Volume

Enrollment Rate at the End of the 6-month Recruitment Period

+7 more

Secondary outcome measures

Percentage of Participants Maintaining a BMI Z-score Less Than -3.0

Side effects data

From 2022 Phase 2 trial • 132 Patients • NCT03634488

Malaria

Fever

Anemia

Acute Chest Syndrome

Prolonged hospitalization

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Ready-to-use Therapeutic Food and Hydroxyurea

Ready-to-use Therapeutic Food Alone

Siblings Without SCD

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SCD - Ready-to-use therapeutic food and HydroxyureaExperimental Treatment2 Interventions

50-75 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive ready-to-use therapeutic food and hydroxyurea (20mg/kg/day)

Group II: SCD - Ready-to-use therapeutic food alonePlacebo Group1 Intervention

50-75 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive ready-to-use therapeutic food alone

Group III: Non-SCD siblings with severe malnutritionPlacebo Group1 Intervention

To decrease the likelihood of sharing limited food resources, we will enroll up to 100 malnourished non-SCD siblings.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ready-to-use therapeutic food

2021

Completed Phase 2

~140

hydroxyurea (20mg/kg/day)

2021

Completed Phase 2

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Murtala Muhammad Specialist HospitalUNKNOWN

1 Previous Clinical Trials

400 Total Patients Enrolled

Aminu Kano Teaching HospitalOTHER

15 Previous Clinical Trials

7,618 Total Patients Enrolled

4 Trials studying Sickle Cell Anemia

749 Patients Enrolled for Sickle Cell Anemia

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,061 Total Patients Enrolled

4 Trials studying Sickle Cell Anemia

749 Patients Enrolled for Sickle Cell Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55+ being recruited for this trial?

"Currently, this clinical trial is only enrolling children who fall between the ages of 5-12 years old."

Answered by AI

Has the FDA cleared hydroxyurea for use at a dosage of 20mg/kg/day?

"While there is some evidence to support hydroxyurea's safety, as this is only a Phase 2 trial, there is not yet any data supporting its efficacy. Therefore, it received a score of 2."

Answered by AI

Are researchers recruiting for this trial at this time?

"From what is available on clinicaltrials.gov, it appears that this trial is still looking for participants. This study was first advertised on August 18th, 2021 and received its latest update on August 25th, 2022."

Answered by AI

What indications warrant a hydroxyurea (20mg/kg/day) prescription?

"Hydroxyurea, at a dosage of 20mg/kg/day, can be used to treat malignant melanoma of the skin, hypereosinophilic syndrome (HES), and neoplasm metastasis."

Answered by AI

Are there specific conditions that make someone ineligible for this trial?

"This clinical trial is admitting 100 patients with severe acute malnutrition between the ages of 5 and 12. Most notable, candidates are required to meet the following criteria: uncomplicated malnutrition (good appetite, alert, no signs of infection of respiratory distress), severe malnutrition defined as a BMI z-score < -3, age between 5 and 12 years (assessment can take place up until the 13th birthday)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Management of Severe Acute Malnutrition in SCD, in Northern Nigeria

Michael DeBaun 2021. "Management of Severe Acute Malnutrition in SCD, in Northern Nigeria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03634488.