Sickle Cell Anemia Clinical Trial
Official title:
Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria
Verified date | February 2024 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Except for children with HIV, all recommendations for treatment of childhood malnutrition are for children < 5 years of age. The overall goal of this randomized controlled nutrition feasibility trial is to identify whether families of children with sickle cell disease (SCD) 5 years and older agree to participate over a 12-week period. The investigators will also establish a safety protocol for monitoring potential complications associated with treating severe malnutrition in children 5 years and older with and without SCD, in a low-resource setting.
Status | Completed |
Enrollment | 132 |
Est. completion date | November 9, 2022 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: - confirmed diagnoses of SCA, comparison children without SCD - severe malnutrition defined as a BMI z-score < -3 - age between 5 and 12 years (assessment can take place up until the 13th birthday) - pass the appetite test - uncomplicated malnutrition (good appetite, alert, no signs of infection of respiratory distress) Exclusion Criteria: - children with complicated severe acute malnutrition - children with electrolyte disturbances (serum Na, K, PO4) at baseline - children on disease-modifying therapy (hydroxyurea or regular blood transfusion therapy) - children enrolled in other studies - children with diabetes and other chronic illnesses - children with known HIV infection - children with a known allergy to dairy or peanuts. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Aminu Kano Teaching Hospital | Kano | |
Nigeria | Murtala Mohammad Specialist Hospital | Kano | |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Aminu Kano Teaching Hospital, Murtala Muhammad Specialist Hospital |
United States, Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrollment Rate at the End of the 6-month Recruitment Period | Recruitment Feasibility: The primary outcome is the proportion of eligible individuals that agree to be included, referred to as the recruitment rate. Children with severe malnutrition who qualified and agreed to participate were invited to sign a consent and assent for study recruitment to this study. | 6 months | |
Primary | Retention Over 12-week Period | The primary outcome is the proportion of participants who completed the 12-week trial, known as the retention rate for the trial. | 12 weeks | |
Primary | Percentage of Ready-to-use Therapeutic Food Sachets Returned as Empty. | Adherence to the ready-to-use therapeutic food was evaluated based on the percentage of empty food sachets returned at each visit. | 12 weeks | |
Primary | Number of Missed Visits | Adherence to monthly visits was assessed based on the number of missed visits | 12 weeks | |
Primary | Percentage of Hydroxyurea Pills Returned | Adherence to hydroxyurea was evaluated based on the percentage of hydroxyurea pills returned for the group randomized to both ready-to-use therapeutic food and hydroxyurea. | 12 weeks | |
Primary | Change in Mean Corpuscular Volume | Adherence to hydroxyurea was evaluated based on change in mean corpuscular volume | 12 weeks | |
Primary | Change in Fetal Hemoglobin Level Percentage | The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the change in fetal hemoglobin level percentage. | Baseline to 12 weeks | |
Primary | Mean Corpuscular Volume Values at Exit | The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on mean corpuscular volume (MCV) values at exit (12 weeks). | Feasibility over 12-week Period [Time Frame: 3 months] | |
Primary | Fetal Hemoglobin Levels at Exit | The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the fetal hemoglobin levels at exit (12 weeks). | Feasibility over 12-week Period [Time Frame: 3 months] | |
Primary | Total Hemoglobin Levels at Exit | The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the total hemoglobin levels at exit (12 weeks). | Feasibility over 12-week Period [Time Frame: 3 months] | |
Secondary | Percentage of Participants Maintaining a BMI Z-score Less Than -3.0 | As a secondary outcome, we assessed the percentage of participants with and without SCA who continued to have a body mass index z-score of <-3.0 at the end of the 12 weeks of treatment. Using the World Health Organization (WHO) growth reference, anthropometric measurements were converted to age and sex-specific z-scores. Anthropometric Indices (BMI-for-age (BMIZ), were calculated using WHO 2007 R Macro Package to assess growth and development of the children. Severe malnutrition/wasting (SAM) was defined as a body mass index (BMI) z-score <-3.0. | 12 weeks |
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