Anemia Clinical Trial
— OptiMOfficial title:
Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
Verified date | October 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Daily iron (ferrous sulfate, 2 mg/kg/day) or placebo syrup for first four months (112 days) of the 12-month (336-day) study. Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Children in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months.
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 48 Months |
Eligibility | Inclusion Criteria for children with malaria: - Hemoglobin 7.0 - 9.9 g/dL - ZPP > = 80 µmol/mol heme - P. falciparum positive by Giemsa smear or RDT positive - Temperature = 37.5C or history of fever in past 24 hours Exclusion Criteria for Children with Malaria: - Any WHO criterion for severe malaria, including severe anemia, prostration, cerebral malaria, repeated seizures or symptoms like persistent vomiting, high temperature (>39.5°C), or tea-colored urine - Severe malnutrition, as evidenced by severe wasting or bilateral pitting edema - Known sickle cell disease - Acute hemorrhage - Known cancer or leukemia - Caregiver does not understand English or Luganda Inclusion Criteria for Community Children: - Same neighborhood, extended household or nearby neighborhood of a child with malaria - Same age group as a child with malaria - Hemoglobin > = 10.0 g/dL Exclusion Criteria for Community Children - Clinical malaria infection or any active illness within the past 4 weeks requiring medical care - Chronic illness requiring medical care - Major medical abnormalities on screening history or physical exam, including measured temperature = 37.5°C - Known developmental delay or neurologic disorder - Prior history of coma - Caregiver does not understand English or Luganda - Other severe illness such as pneumonia or cardiac failure |
Country | Name | City | State |
---|---|---|---|
Uganda | Kampala, Uganda | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of iron deficiency | Number of participants who are iron deficient (defined as a zinc protoporphyrin (ZPP) concentration greater than or equal to 80 umol/mol heme) at 6-months follow-up in the early iron vs. delayed iron treatment groups | 6-months | |
Primary | All-cause incidence of infectious illness | Number of participants who report an infection and total number of infections reported to a study medical officer in the early iron vs. delayed iron treatment groups. This includes all infectious illness including clinical malaria episodes. | 6-months | |
Primary | Effect on neurobehavioral development: BRS | Behavior Rating Scales (BRS) scores at 12 months follow up in the early iron vs. delayed iron treatment groups. BRS assesses socioemotional behavior. Scores range from 1-5. Higher raw scores for Fearful/Wary Affect, Negative Affect, and Hyperactivity/Over-activity indicate less optimal behavior, as do lower raw scores for Positive Affect, Adaptation to Change, Exploration and Activity Level. | 12-months | |
Primary | Effect on neurobehavioral development: MSEL | Mullen Scales of Early Learning (MSEL) scores at 12 months follow up in the early iron vs. delayed iron treatment groups.The MSEL assesses motor, visual, and language ability and is used to measure cognitive ability. Scores from fine motor, visual reception, receptive language, and expressive language scales are summed to give the early learning composite score, a measure of overall cognitive ability. Each sub-scale is standardized to calculate a standard score, percentile, and age-equivalent score. Composite scores range from 0 to 100 with 100 indicating greater cognitive ability. | 12-months | |
Secondary | ZPP | Prevalence of zinc protoporphyrin (ZPP) = 80 umol/mol heme in the early iron vs. delayed iron treatment groups | 12-months | |
Secondary | Iron status: Hemoglobin | Concentrations of hemoglobin in the immediate vs. delayed groups | 6- and 12-months | |
Secondary | Iron status: ferritin | Concentrations of ferritin in the early iron vs. delayed iron treatment groups | 6- and 12-months | |
Secondary | Iron status: soluble transferrin receptor (sTFR) | Concentrations of sTFR in the early iron vs. delayed iron treatment groups | 6- and 12-months | |
Secondary | Iron status: hepcidin | Concentrations of hepcidin in the early iron vs. delayed iron treatment groups | 6- and 12-months | |
Secondary | Iron status: C-reactive Protein (CRP) | Concentrations of CRP in the early iron vs. delayed iron treatment groups | 6- and 12-months | |
Secondary | All-cause infectious episodes | Incidence of all-cause infectious episodes and incidence of clinical malaria episodes during the 12-months follow-up period; incidence of all-cause and malaria-specific hospitalizations | 12-months | |
Secondary | Proteobacteria | Change in relative fecal abundance of Proteobacteria | Baseline, 6-months, 12-months | |
Secondary | Child Behavior Checklist (CBCL) | CBCL scores at 12 months follow up. Preschool Child Behavioral Checklist (P-CBCL) is a parent-report checklist that assesses internalizing, externalizing, and total behavioral problems. Higher scores indicate more problematic behavior or diminished function. | 12-months | |
Secondary | Behaviors Related to Executive Function (BRIEF) | BRIEF scores at 12 months follow up. Behavior Rating Inventory of Executive Functioning, Preschool edition (BRIEF-P) is a parent-report checklist that assesses global executive function. Higher scores indicate more problematic behavior or diminished function. | 12-months |
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