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.: PACTR201410000896410 Date of Approval: 29/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy study of the consumption of milk fortified in vitamins and minerals
Official scientific title Efficiency study of iodine fortification of milk on iodine status markers: A longitudinal interventional non randomized, controlled study among school children in Morocco
Brief summary describing the background and objectives of the trial Abstract Background: Iodine deficiency is prevalent worldwide and can affect growth, mental development and learning ability of school children. In line with the Moroccan National Strategy for Nutrition 2011¿2019, we undertook a study to evaluate the efficiency of the consumption of iodine fortified milk on iodine status of children living in rural region. Methods: The study is a longitudinal, interventional double-blinded, placebo controlled one concerning 191 children, aged 7 to 9 years, recruited from 3 schools in a rural, high altitude province in Morocco. The sample was divided in two groups: a non-fortified milk group (NFM, n=103) received 200ml of non-fortified Ultra High Temperature (UHT) milk and a fortified milk group (FM, n=50) received 200ml UHT milk fortified with iodine persulfate to cover 30% of Recommended Daily Intake. Urine samples were collected at baseline, 4th and 9th months and urinary iodine was determined spectrophotometrically using the Sandell-Kolthoff reaction. All statistical analyses were performed using Statistical Package for the Social Sciences (version 17.0).
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PEN
Disease(s) or condition(s) being studied Micronutrient deficiencies
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2012
Actual trial start date 01/02/2012
Anticipated date of last follow up 31/10/2012
Actual Last follow-up date 31/10/2012
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Non-randomised Numbered containers Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Efficiency study of multiple micronutrients fortification of milk on nutritional status 20.8 µg of iodine, less than 0.4mg of iron, less than 1µg of Vit D, 54µg of vit A naturally existing in regular milk per 200ml serving per day 9 months A longitudinal interventional non randomized, controlled study among school children in Morocco 120 Placebo
Experimental Group Efficiency study of multiple micronutrients fortification of milk on nutritional status 45 µg of K iodide, 4.2mg of iron sulfate,3µg of cholecalciferol,240µg of retinyl palmitate per 200ml serving per day 9 months 200 ml of vanilla flavored UHT milk, fortified with iodine to cover 30% of RDI, was distributed daily to school children including holidays. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in the study, children had to be aged between 7 and 9 years and should not take supplements during the study period Children with severe malnutrition needing nutritional rehabilitation, or having chronic or severe illness requiring hospitalization or treatment were excluded from the study 7 Year(s) 9 Year(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 01/02/2012 General secretariat of the ministry of education
Ethics Committee Address
Street address City Postal code Country
General secretariat of the ministry of education Rabat 10000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Data analysis clearly demonstrated the amelioration of iodine status in fortified and non-fortified milk groups. Severe and mild iodine deficiencies were reduced for both groups. Moreover, there¿s complete disappearance of severe deficient cases in the fortified milk group after 4 months of intervention. January 2013
Secondary Outcome ongoing ongoing
Primary Outcome The prevalence of vitamin A deficiency for the fortified group dropped from 50% at baseline to 4.3% at end line compared to non-fortified group where it dropped from 44% to 24.8%. The difference between both groups was highly significant (p<0.0001). January 2013
Primary Outcome Results of the fortified group showed that the prevalence of iron deficiency anemia (IDA) dropped from 1.8% at baseline to 0% at endline and prevalence of iron deficiency (ID) dropped significantly from 50.9% to 37.2% (p=0.037) compared to the non-fortified group where prevalences remained stable for both IDA and ID. January 2013
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abu Antar School Commune of Ouaoula Azilal 22000 Morocco
Iwariden and Iminifri schools Commune of Tifni Azilal 22000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibn Tofail University BP 133, Campus Ibn Tofail University Kenitra 14000 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibn Tofail University BP 133, Campus Ibn Tofail University Kenitra 14000 Morocco University
COLLABORATORS
Name Street address City Postal code Country
Ministry of Education Ministry of Education, Bab Rouah Rabat 10000 Morocco
Ministry of health, Population departement Avenue Hassan II Rabat 10000 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 Hassan Aguenaou aguenaou2014@gmail.com +212 6 63 75 67 30
City Postal code Country Position/Affiliation
Morocco
REPORTING
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