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.: PACTR201906885776793 Date of Registration: 06/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of an iron fortified complementary food in improving the nutritional status of children aged 6-18 months in the La Nkwantanang Municipality of the Greater Accra Region
Official scientific title Efficacy of an iron fortified complementary food in improving the nutritional status of children aged 6-18 months in the La Nkwantanang Municipality of the Greater Accra Region
Brief summary describing the background and objectives of the trial Anemia remains widely prevalent in Ghana, affecting about 75% of children aged 6-23 months, with iron deficiency a common cause. The objective of this study is to assess the effect of a micronutrient-fortified complementary food on hemoglobin, anemia prevalence, and growth of infants in the La Nkwantanang Municipality of the Greater Accra Region, Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 30/04/2017
Actual Last follow-up date 30/09/2017
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 208
Recruitment status Completed
Publication URL https://www.eventscribe.com/2019/ASN/PosterTitles.asp?pfp=PosterTitle
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group 50 g/day for subjects aged 6 - 8 months, 75 g/day for subjects aged 9 - 11 months, and 100 g/day for subjects aged 12 - 18 months 6 months micronutrient fortified infant cereal without iron 101 Placebo
Experimental Group Intervention group 50 g/day for subjects aged 6 - 8 months, 75 g/day for subjects aged 9 - 11 months, and 100 g/day for subjects aged 12 - 18 months 6 months micronutrient fortified infant cereal with iron (3.5 mg iron / 50 g cereal) 107
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Child age is between 6 and 18 months Parents / caregivers live in the study area with no plans to move Parents / caregivers able and willing to participate in the study Child has an acute or chronic illness Child is taking medication due to recent ailment Child is allergic to wheat-based foods Infant: 13 Month(s)-24 Month(s) 6 Month(s) 18 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 04/01/2017 Noguchi Memorial Institute for Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
PO Box LG 581 Legon Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin concentration 0, 2, 4, 6, and 8 months
Secondary Outcome Weight 0, 2, 4, 6 and 8 months
Secondary Outcome Height 0, 2, 4, 6, and 8 months
Secondary Outcome Mid-upper arm circumference 0, 2, 4, 6, and 8 months
Secondary Outcome Dietary intake assessment 0, 6 and 8 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Noguchi Memorial Institute for Medical Research PO Box LG 581 Legon Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Nestle Company Limited Ghana Heavy Ind. Area Tema 8350 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nestec Ltd Avenue Nestle 55 Vevey 1800 Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Frederick Vuvor PO Box LG 134 Legon 00233 Ghana
Richard S. Ansong PO Box LG 134 Legon 00233 Ghana
Obed Akwaa Harrison PO Box LG 134 Legon 00233 Ghana
Godfred Egbi PO Box LG 134 Legon 00233 Ghana
Matilda Steiner Asiedu PO Box LG 134 Legon 00233 Ghana
Nicholas Hays Rue Entre-deux-Villes 10 La Tour de Peilz 1814 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matilda Steiner Asiedu tillysteiner@gmail.com +233541260704 PO Box LG 134
City Postal code Country Position/Affiliation
Legon 00233 Ghana Dean School of Biological Sciences University of Ghana
Role Name Email Phone Street address
Public Enquiries Matilda Steiner Asiedu tillysteiner@gmail.com +233541260704 PO Box LG 134
City Postal code Country Position/Affiliation
Legon 00233 Ghana Dean School of Biological Sciences University of Ghana
Role Name Email Phone Street address
Scientific Enquiries Matilda Steiner Asiedu tillysteiner@gmail.com +233541260704 PO Box LG 134
City Postal code Country Position/Affiliation
Legon 00233 Ghana Dean School of Biological Sciences University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices). Clinical Study Report,Informed Consent Form,Study Protocol Beginning 3 months following article publication Investigators who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the Principal Investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not_yet_available Yes There were no significant differences between groups in maternal/household characteristics or infant baseline anthropometry. At 6 months, adjusted mean±SE hemoglobin (Hb) change from baseline in control (CTL) and intervention (INT) groups was 1.16 ± 0.21 and 1.97 ± 0.19 g/dL, respectively (p < 0.01 for each); the increase over time was significantly larger in INT vs. CTL (0.68 ± 0.30 g/dL; p = 0.02). Similar results were found in unadjusted models. Hb levels declined slightly in both groups in the 2 month period after the intervention but remained higher in INT. Prevalence of anemia declined in both groups (CTL: 89.1% to 62.8%, INT: 84.1% to 42.8%); the magnitude of decrease was 57% greater in INT. There was no significant difference between groups in length gain (CTL: 6.24 ± 0.28, INT: 5.62 ± 0.27 cm; p = 0.21) or weight gain (CTL: 1.03 ± 0.24, INT: 1.31 ± 0.24 kg; p = 0.41). Iron-fortified infant cereal consumed for 6 months promoted greater reductions in iron-deficiency anemia in infants aged 6-18 months, which is a public health concern in Ghana and most developing countries. 05/06/2019 09/06/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks no_link_available
Changes to trial information