Safety and benefit of iron supplementation in HIV infected children
| ISRCTN | ISRCTN62947977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62947977 |
| Secondary identifying numbers | 1 |
- 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
Scientific
Malawi-Liverpool Wellcome Trust
College of Medicine
University of Malawi
PO Box 30096
Blantyre
3
Malawi
Study information
| Study design | Double-blind, randomised, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 15/09/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1,260 |
| 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
3
Malawi
Sponsor information
Liverpool School of Tropical Medicine (UK)
University/education
University/education
Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Website | http://www.liv.ac.uk/lstm |
|---|---|
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Research organisation
The Netherlands-African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAP) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
