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Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas (OptiM)

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ClinicalTrials.gov Identifier: NCT03897673
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Iron-deficiency Anemia, Iron Deficiency Anemia Anemia in Children Malaria Dietary Supplement: Early Iron Dietary Supplement: Delayed Iron Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Malaria

Arm Intervention/treatment
Experimental: Early Iron
Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month.
Dietary Supplement: Early Iron
iron syrup for the first three months (84 days) and placebo syrup for the fourth month

Experimental: Delayed Iron
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.
Dietary Supplement: Delayed Iron
placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months

No Intervention: Community Control Children
Healthy, non-anemic community children will be enrolled from the same households and villages as the children with malaria. They will not have ZPP tested or receive iron, but they will also be under the same illness surveillance as the children with malaria.



Primary Outcome Measures :
  1. Prevalence of iron deficiency [ Time Frame: 6-months ]
    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

  2. All-cause incidence of infectious illness [ Time Frame: 6-months ]
    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.

  3. Effect on neurobehavioral development: BRS [ Time Frame: 12-months ]
    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.

  4. Effect on neurobehavioral development: MSEL [ Time Frame: 12-months ]
    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.


Secondary Outcome Measures :
  1. ZPP [ Time Frame: 12-months ]
    Prevalence of zinc protoporphyrin (ZPP) ≥ 80 umol/mol heme in the early iron vs. delayed iron treatment groups

  2. Iron status: Hemoglobin [ Time Frame: 6- and 12-months ]
    Concentrations of hemoglobin in the immediate vs. delayed groups

  3. Iron status: ferritin [ Time Frame: 6- and 12-months ]
    Concentrations of ferritin in the early iron vs. delayed iron treatment groups

  4. Iron status: soluble transferrin receptor (sTFR) [ Time Frame: 6- and 12-months ]
    Concentrations of sTFR in the early iron vs. delayed iron treatment groups

  5. Iron status: hepcidin [ Time Frame: 6- and 12-months ]
    Concentrations of hepcidin in the early iron vs. delayed iron treatment groups

  6. Iron status: C-reactive Protein (CRP) [ Time Frame: 6- and 12-months ]
    Concentrations of CRP in the early iron vs. delayed iron treatment groups

  7. All-cause infectious episodes [ Time Frame: 12-months ]
    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

  8. Proteobacteria [ Time Frame: Baseline, 6-months, 12-months ]
    Change in relative fecal abundance of Proteobacteria

  9. Child Behavior Checklist (CBCL) [ Time Frame: 12-months ]
    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.

  10. Behaviors Related to Executive Function (BRIEF) [ Time Frame: 12-months ]
    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.



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Ages Eligible for Study:   6 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897673


Locations
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Uganda
Kampala, Uganda
Kampala, Uganda
Sponsors and Collaborators
University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03897673     History of Changes
Other Study ID Numbers: STUDY00001235
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs