Safety and benefit of iron supplementation in HIV infected children

ISRCTN	ISRCTN62947977
DOI	https://doi.org/10.1186/ISRCTN62947977
Protocol serial number	1
Sponsor	Liverpool School of Tropical Medicine (UK)
Funder	The Netherlands-African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAP) (The Netherlands)

Submission date: 14/08/2008
Registration date: 30/09/2008
Last edited: 22/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kamija Phiri
Scientific

Malawi-Liverpool Wellcome Trust
College of Medicine
University of Malawi
PO Box 30096
Blantyre
3
Malawi

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Double-blind, randomised, placebo-controlled trial of iron supplementation in HIV-infected Malawian children: Is it safe and beneficial?
Study acronym	HI Study
Study objectives	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(s)	College of Medicine Research and Ethics Committee, University of Malawi. Date of approval: 28/07/2008 (ref: P.03/08/623)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The incidence of all-cause sick visits during the trial and follow up period.
Key secondary outcome measure(s)	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)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	1260
Key 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
Key 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
Date of first enrolment	15/09/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Malawi

Study participating centre

Malawi-Liverpool Wellcome Trust

Blantyre
3
Malawi

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes