Condition category
Infections and Infestations
Date applied
14/08/2008
Date assigned
30/09/2008
Last edited
22/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nwo.nl/nwohome.nsf/pages/NWOA_6LRBKV_Eng

Contact information

Type

Scientific

Primary contact

Dr Kamija Phiri

ORCID ID

Contact details

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

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

http://www.liv.ac.uk/lstm

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

  1. 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.

Additional files

Editorial Notes