Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807163544658 Date of Approval: 18/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of maternal HIV status on breast milk intake and growth of HIV-uninfected Kenyan infants at 6 weeks post-partum and 6 months of age
Official scientific title Breast milk intake among HIV-exposed unifected and 6 weeks and 6 months postpartum
Brief summary describing the background and objectives of the trial Background: All infants irrespective of their HIV status and that of their mothers should be exclusively breastfed in their first half of infancy. It is however not well known if infants¿ exposure to maternal HIV infection does affect their breast milk intake, linear growth and body composition. Objectives: To compare breast milk intake of HIV-uninfected infants born of HIV-positive mothers with that of infants born of HIV-negative mothers at 6 weeks and 6 months of age. Additionally, the study aimed to assess the effect of maternal HIV status on infant growth, body composition (lean mass) and breastfeeding practices among the mothers.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/02/2014
Actual trial start date 01/02/2014
Anticipated date of last follow up 01/05/2015
Actual Last follow-up date 06/07/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 133
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised n/a Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HIV exposure 6 months HIV-negative children born of HIV-positive mothers 60
Control Group HIV uninfected unexposed 6 months Infants born of HIV-negative mothers 60 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mother-infants dyads of 6 weeks old HIV-uninfected infants were eligible for this study. The following infants were excluded: infants having <2500g birth weight, preterm infants, infants not able to breastfeed, infants or mothers showing signs of chronic illnesses (as was determined by the project nurse). To minimise loss to follow-up, those intending to move away from Siaya District 7-10 months from the date of recruitment into the study were also excluded. Infant: 1 Month-23 Month 6 Week(s) 6 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2013 KNH UoN Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 19676 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome infant breast milk intake 6 weeks postpartum and 6 months postpartum
Secondary Outcome Infant growth 6 weeks after birth and 6 months after birth
Secondary Outcome body composition 6 weeks and 6 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Siaya County Referral Hospital Siaya Town Siaya P. O Box 144 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
International Atomic Energy Agency P. O Box 100, Vienna 1400 Austria
Nutricia Research Foundation 11 Biopolis Way, Helios 09-01-02 Singapre 00000 Singapore
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Nairobi Insitute of Tropical and Infectious Diseases (UNITID) Ngong Road, Nairobi Nairobi P.O. Box 19676 - 002 Kenya University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street London London, WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shadrack Oiye oiyeshad@gmail.com +254722759449 P O Box 17094. 00510, Nairobi Kenya
City Postal code Country Position/Affiliation
Nairobi 00510 Kenya University of Nairobi Institute of Tropical and Infectious Diseases
Role Name Email Phone Street address
Public Enquiries Shadrack Oiye oiyeshad@gmail.com +254722759449 P. O Box 17094, 00510
City Postal code Country Position/Affiliation
Nairobi 00510 Kenya University of Nairobi Institute of Tropical and Infectious Diseases
Role Name Email Phone Street address
Scientific Enquiries Shadrack Oiye oiyeshad@gmail.com +254722759449 P.O Box 17094, 00510
City Postal code Country Position/Affiliation
Nairobi 00510 Kenya University of Nairobi Institute of Tropical and Infectious Diseases
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information