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Safety and benefit of iron supplementation in HIV infected children

Double-blind, randomised, placebo-controlled trial of iron supplementation in HIV-infected Malawian children: Is it safe and beneficial?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62947977
Enrollment
1260
Registered
2008-09-30
Start date
2008-09-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV and iron deficiency Infections and Infestations Unspecified human immunodeficiency virus [HIV] disease

Interventions

The participants will be randomly allocated to the following arms: Arm 1: Supplementation of oral multi-vitamins with iron, (3 mg/kg body weight/day) for 3 months Arm 2: Oral multi-vitamins alone for

Sponsors

Liverpool School of Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age 6-59 months 2. Presence of moderate anaemia (haemoglobin 7-9.9 g/dl) 3. HIV positive 4. Mean corpuscular volume (MCV) <=73 f/l (for children from 2-5 years); <=67 f/l (for children <2 years) 5. Informed consent by parent/guardian

Exclusion criteria

Exclusion criteria: 1. Patients already on nutritional supplements 2. Presence of gross congenital, cognitive or neuro-developmental anomalies 3. Children with malnutrition requiring supplementary feeding; weight-for-height less than 80% of expected; presence of bipedal oedema 4. Patients with haemoglobin =10 g/dl

Design outcomes

Primary

MeasureTime frame
The incidence of all-cause sick visits during the trial and follow up period.

Secondary

MeasureTime frame
1. Incidence of all-cause hospitalisations during the trial and follow up period 2. Incidence of haemoglobin <7 g/dl during the follow up period of 6 months 3. Laboratory diagnosis of acquired immune deficiency syndrome (AIDS) or clinical stage IV disease, patient requiring highly active antiretroviral treatment (HAART)

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026