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.: PACTR202004874656680 Date of Registration: 29/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial to study the effects Multiple Micronutrient supplementation on selenium levels in the breast milk and serum of lactating mothers in Plateau state, Nigeria.
Official scientific title Multiple Micronutrient Supplementation of Lactating Mothers using Multiple Micronutrient Supplements and Its Effect on Maternal Breast Milk and Serum Selenium Levels and Infants Nutritional Status in Plateau State, Nigeria.
Brief summary describing the background and objectives of the trial Background: Although the impact of micronutrient supplementation during pregnancy has been well established, micronutrient deficiency still remains a problem of public health significant amongst pregnant and lactating mothers in developing countries including Nigeria. While several micronutrients have been explored in the breast milk of lactating mothers, very limited studies have explored breast milk selenium profile, maternal supplementation and its implication on the nutritional status of infants (Allen & Dror, 2018). Methods: This study is a prospective, randomized, double-blind trial involving 66 mothers - infant pair attending post-natal clinics at selected primary, secondary, and tertiary health Care Facilities would be recruited into this study. They will be randomized to receive daily Multiple Micronutrient supplements (MMS) containing 65ug /day of placebo for 10 weeks. A 10 ml sample of breast milk and 5ml of blood will be collected from lactating women at the start, 6 weeks, and 10 weeks. Selenium levels in plasma and breast milk would be analyzed using Atomic Absorption Spectrophotometer. The weight, length, and head circumference of the infant will be collected. Anthropometric measurements of mothers and children will be obtained at each visit. All participants would complete a validated 24hr dietary Recall in order to determine the level of selenium intake in the diet. Demographic characteristics and other lifestyle factors would be assessed using a validated Questionnaire. Data obtained from the study would be analyzed using SPSS software version 23. Discussion: - The outcome from the study would provide additional evidence on the effect of Multiple Micronutrient Supplementation human milk and serum selenium levels. The findings from the study would provide evidence based results that would influence national health policy on maternal supplementation of pregnant and lactating mothers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2020
Actual trial start date
Anticipated date of last follow up 29/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 65ug selenium in MMS 65ug selenium in MMS - once daily 10 weeks Mothers who met the inclusion criteria would be administered 65µg/day of selenium in MMS capsules for 10 weeks. While the control mothers would be given placebo. Both groups will not be on any multivitamins only the routine postnatal hematinic and should be exclusively breastfeeding. Any child who falls ill and will need medication or admission during the course of the study will be excluded from the study. A 10 ml sample of breast milk and 5ml of blood will be collected from lactating women at start, 6 weeks and 10 weeks. Selenium levels in plasma and breast milk would be analyzed using Atomic Absorption Spectrophotometer. The weight and length of the infant will be obtained using a seca bassinet scale and infantometer respectively. Head circumference will also be measured using a non-distensible tape at baseline, 4 weeks and 8 weeks of selenium supplementation. Data obtained from the study would be analyzed using STATA and R-Studio . 33
Control Group placebo once daily (OD) 10 weeks Mothers who met the inclusion criteria and randomised into the control group would be administered placebo daily selenium for 10 weeks. The mother must not be on any multivitamins only the routine postnatal hematinic and should be exclusively breastfeeding. Any child who falls ill and will need medication or admission during the course of the study will be excluded from the study. A 10 ml sample of breast milk and 5ml of blood will be collected from lactating women at start, 6 weeks and 10 weeks. Selenium levels in plasma and breast milk would be analyzed using Atomic Absorption Spectrophotometer (Buck Scientific Model 205, United States of America). The weight and length of the infant will be obtained using a seca bassinet scale and infantometer respectively. Head circumference will also be measured using a non-distensible tape at baseline, 6 weeks and 10 weeks of selenium supplementation. Data obtained from the study would be analyzed using SPSS software version 23 for statistical operations. Chi-square, Student's t-tests, Independent sample t –test, α2 test and ANCOVA would be used to compare the baseline continuous and categorical variables will be used where appropriate, to compare the variables between the two groups studied. 33 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Lactating mothers and child pair with full-term delivery within the first 5 days of delivery would be recruited for the study. • Mother – child pair eligible for recruitment must be on Exclusive breastfeeding and give commitment to continue with EBF all through the duration of the study. Exclusively breastfeeding mothers. • Mothers below 19 years and above 44 years of age and child pair. • Mothers who are not on exclusively breastfeeding. • Babies who have congenital disorders or are ill at the time of recruitment. • Mothers with multiple births (Twins, triplets etc.). • Mothers having a chronic illness (TB, Diabetes mellitus). • Mothers on any other micronutrient supplements containing selenium prior to recruitment. Adult: 18 Year(s)-44 Year(s) 19 Year(s) 44 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 23/10/2019 UI UCH Ethics committee
Ethics Committee Address
Street address City Postal code Country
Institute of Advance Medical Research and Training, College of Medicine, University of Ibdan. Ibadan 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Breast milk selenium levels 4th and 8th week
Primary Outcome Plasma Selenium levels 4th and 8th week
Secondary Outcome Infant nutritional status 4th and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Plateau State Specialist Hospital Hospital Road, Secretariat junction, Plateau State Plateau 23401 Nigeria
Jos North Primary Health Care Township stadium, Jos North Plateau State Nigeria
Comprehensive Health Care Dadinkowa, Plateau State Plateau Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
International Society for Research in Human Milk and Lactation 3355 West Alabama St., Suite 640 Houston TX 77098, United States. Houston TX 77098 United States of America
Vitamin Angels 6500 Hollister Ave, Suite 130. Goleta, CA 93117 CA United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kayode Adedamola University of Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Folake Samuel Department of Human Nutrition, Faculty of Public Health, University of Ibadan, Nigeria Ibadan Nigeria
Ruth Adah Jos University Teaching Hospital, Department of Paediatrics, Plateau State Plateau Nigeria
Donna Geddes University of Western Australia, 35 Stirling Highway Perth WA 6009 Australia Perth Australia
Ching T. Lai University of Western Australia, 35 Stirling Highway Perth WA 6009 Australia Perth Australia
Lucius Imoh Department of Chemical Pathology, Jos University of Technology Jos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omobolaji Adewuyi bolajiadewuyi@yahoo.co.uk +2347035188537 Department of Human Nutrition, Faculty of Public Health, University of Ibadan, Nigeria
City Postal code Country Position/Affiliation
Ibadan Nigeria Doctorate Research Fellow
Role Name Email Phone Street address
Public Enquiries Omobolaji Adewuyi bolajiadewuyi@yahoo.co.uk +2347035188537 Department of Human Nutrition, Faculty of Public Health, University of Ibadan, Nigeria
City Postal code Country Position/Affiliation
Ibadan Nigeria Lecturer Department of Nutrition and Dietetics Ladoke Akintola University of Technology
Role Name Email Phone Street address
Scientific Enquiries Omobolaji Adewuyi bolajiadewuyi@yahoo.co.uk +2347035188537 Department of Human Nutrition, Faculty of Public Health, University of Ibadan, Nigeria
City Postal code Country Position/Affiliation
Ibadan Nigeria Doctorate Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the primary and secondary objectives after de-identification (texts, tables, figures, and appendixes). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 3 years following article publication. Researchers whose intended use of the data has been approved by a Scientific Committee.
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