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.: PACTR201512001217212 Date of Approval: 24/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined consumption of a single high-dose vitamin A supplement and provision of vitamin A fortified oil to households maintains adequate milk retinol
Official scientific title Combined consumption of a single high-dose vitamin A supplement and provision of vitamin A fortified oil to households maintains adequate milk retinol concentrations for 6 months in lactating Moroccan women
Brief summary describing the background and objectives of the trial Background:In Morocco, post-partum women systematically receive a single high-dose of vitamin A (VA) (200 000 IU), within the first month of giving birth and vegetable oil is fortified with (30 IU/g of oil) as retinyl palmitate to increase the VA intake. The efficacy of this combined approach of supplementation and fortification for increasing maternal VA status during lactation is not known. Objective: To evaluate the effect of post-partum high dose VA supplementation and provision of VA fortified oil for household consumption on plasma and milk retinol concentrations of lactating Moroccan women during the first 6 mo post-partum.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Vitamin A deficiency
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/02/2009
Actual trial start date 02/02/2009
Anticipated date of last follow up 26/07/2010
Actual Last follow-up date 26/07/2010
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 140
Recruitment status Stopped early/ terminated
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 Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin A supplementation and vitamin A fortification vitamin A supplementation(200 000 IU) , for fortification (30 IU/g of oil) 18 months All women received a capsule containing 200.000 IU of vitamin A at 15 days postpartum, then fortified soy oil was delivered weekly to the participants. The quantity of oil delivered to the participants (2 liters/week ) estimated to be sufficient to meet the whole family¿s need. 70
Control Group vitamin A supplementation and non-fortified soy oil vitamin A supplementation 200000 IU at baseline and non-fortified oil the whole period 18 months All women received a capsule containing 200.000 IU of vitamin A at 15 days postpartum, then non-fortified soy oil was delivered weekly to the participants. The quantity of oil delivered to the participants (2 liters/week ) estimated to be sufficient to meet the whole family's need. 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Study participants were mother infant pairs, recruited at 2-3 weeks post-partum from a local maternity hospital in a low-income community in Rabat, Morocco at the time of BCG vaccination of infants. -Mothers were eligible for the study if they were breastfeeding a single infant who was apparently healthy and if they planned to breastfeed for at least 6 mo postpartum -Mothers aged <18 y -presence of acute infections, chronic diseases or signs or symptoms of vitamin A deficiency -Women who became pregnant during the study 19 Year(s) 40 Year(s) Female
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 25/10/2007 Institutional Review Board, University of California, Davis
Ethics Committee Address
Street address City Postal code Country
2921 Stockton Blvd. Suite 1400, Rm.1429 Sacramento California 95817 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vitamin A in human milk Baseline at 15 days of postpartum then monthly till 6 months of postpartum
Secondary Outcome Vitamin A in serum baseline ( at 15 days postpartum) , at 3 months and after 6 months of lactation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
local maternity hospital Takkadoum Rabat 10100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
IAEA Vienna International Centre, Vienna PO Box 100 A-1400 Austria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibn Tofail University BP 133, Campus Ibn Tofail University Kénitra 140000 Morocco University
COLLABORATORS
Name Street address City Postal code Country
CNESTEN Madinat al irfan Rabat B.P. 1382 R.P. 10001 Morocco
Moroccan Ministry of Health 335. Avenue Mohamed V Rabat 10001 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Aguenaou aguenaou2014@gmail.com +212-663756730 Ibn Tofail university, Campus, BP 133
City Postal code Country Position/Affiliation
Kenitra 14000 Morocco Ibn Tofail University
Role Name Email Phone Street address
Public Enquiries Hassan Aguenaou aguenaou2014@gmail.com +212-663756730 Ibn Tofail university, Campus, BP 133
City Postal code Country Position/Affiliation
Kenitra 14000 Morocco Ibn Tofail University
Role Name Email Phone Street address
Scientific Enquiries Asmaa El Hamdouchi asmaaelhamdouchi@gmail.com +212662881963 Madinat Al Irfan
City Postal code Country Position/Affiliation
Rabat BP 1382 RP 10001 Morocco Unité Mixte de Recherche en Nutrition, CNESTEN-Ibn Tofail university
REPORTING
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