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OpenTrials
Completed

NCT Number: NCT03596996

Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children

Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)], HIV-infected Ugandan children between the ages of 6 mos and 12 years.

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Key information

Conditions

Anemia Acquired Immunodeficiency Syndrome Anemia, Hypochromic Anemia, Iron-Deficiency Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Iron-deficiency Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Clinical Research Centre

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of HIV (based JCRC clinic records);
  • On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
  • Age 6 months - 12 years at the time of screening
  • Hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)by CBC at time of screening

Exclusion criteria

  • Acute illness or current opportunistic infection
  • Temperature >= 38.0°C at the time of screening
  • Known sickle cell disease
  • Acute malnutrition (bilateral pitting edema or extreme wasting)
  • Any chronic illness requiring regular medical attention
  • Residence > 50 km from JCRC hospital
  • Non-English or Luganda speaking
  • Currently taking iron supplements

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.

Placebo

Dietary Supplement

Placebo with identical appearance comparison intervention arm

Primary outcomes

  1. Hemoglobin

    Time frame: 3 months

    Measurement of hemoglobin

  2. Anemia

    Time frame: 3 months

    Prevalence of anemia

  3. Iron status

    Time frame: 3 months

    Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma

Secondary outcomes

  1. Sick Child Visits

    Time frame: 3 months

    Number of acute illnesses leading to visit to healthcare provider

  2. Dietary iron absorption

    Time frame: 2 weeks

    Percentage of 57Fe from oral dose that is incorporated into hemoglobin

  3. HIV virologic control

    Time frame: 3 month

    HIV viral load

  4. HIV related immunosuppression

    Time frame: 3 months

    CD4 count

Other outcomes

  1. Microbiome gut profile

    Time frame: 3 months

    Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Joint Clinical Research Center

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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