Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Double-blind, randomised, placebo-controlled trial of iron supplementation in HIV-infected Malawian children: Is it safe and beneficial?
Acronym
HI Study
Study hypothesis
We hypothesise that iron supplementation in anaemic HIV infected children is associated with a positive haematological response without an increased risk of morbidity, HIV disease progression and death.
Ethics approval
College of Medicine Research and Ethics Committee, University of Malawi. Date of approval: 28/07/2008 (ref: P.03/08/623)
Study design
Double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
HIV and iron deficiency
Intervention
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 3 months
Total duration of interventions: 3 months
Total duration of follow-up: 6 months
Intervention type
Supplement
Phase
Not Specified
Drug names
Iron supplementation
Primary outcome measures
The incidence of all-cause sick visits during the trial and follow up period.
Secondary outcome measures
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)
Overall trial start date
15/09/2008
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1,260
Participant 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 <7 g/dl or >=10 g/dl
Recruitment start date
15/09/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Malawi
Trial participating centre
Malawi-Liverpool Wellcome Trust
Blantyre
3
Malawi
Sponsor information
Organisation
Liverpool School of Tropical Medicine (UK)
Sponsor details
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands-African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAP) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23956164
Publication citations
-
Results
Esan MO, van Hensbroek MB, Nkhoma E, Musicha C, White SA, Ter Kuile FO, Phiri KS, Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial., Clin. Infect. Dis., 2013, 57, 11, 1626-1634, doi: 10.1093/cid/cit528.