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.: PACTR201607001693286 Date of Approval: 24/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Micro-nutrient Supplementation
Official scientific title The Efficacy of Multiple Micronutrient Powder Supplementation in Children Under Five Years in Arusha District
Brief summary describing the background and objectives of the trial Childhood malnutrition is a serious problem in Tanzania; it causes more than 43,000 children to die every year. Recently, there are new approaches for the management undernutrition focusing on fortification with multiple micronutrients to combat this threat has become available internationally in children under the age of five years. Cost-effective approaches to reducing micronutrient deficiencies in low income countries are common goals of international health agencies and country. A diversified diet and national food fortification of staple foods are considered to be the optimal approach for minimizing under-nutrition although is limited to rural communities because of unavailability of these fortified foods. Fortification of home-prepared complementary foods has proven effective for preventing and treating micronutrient deficiencies for small children. Parents living in rural Tanzania have very limited income may not be able to buy micronutrient powder sachets for daily consumption. Currently there is no data to provide recommendations for micronutrients consumption in resource poor areas. Such information will be extremely helpful for recommending micronutrients supplement intake and also in social marketing of micronutrients powders.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anemia,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/09/2015
Actual trial start date 07/09/2015
Anticipated date of last follow up 07/03/2016
Actual Last follow-up date 07/03/2016
Anticipated target sample size (number of participants) 436
Actual target sample size (number of participants) 436
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 Computer generated random numbers Allocation was determined by the holder off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Full dose Five days per week consumption of micro-nutrients sachets Six months Children were given 120 sachets on average of 20 sachets per month 40 Active-Treatment of Control Group
Experimental Group 90 Micro-nutrients sachets 3-4 days per week Six moths Children were given 90 sachets providing an average of 15 sachets per month 100 Dose Comparison
Experimental Group 60 Micro-nutrients sachets 2-3 Days per week Six months Children were given 60 satchets providing an avgerage of 10 satcets per month providing 33 % RNI/d 140 Dose Comparison
Experimental Group 40 Micro-nutrients sachets 1-2 days per week Six months Children were given 40 satchets providing an average of 7 satchets per month 156 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The family must be residing within the study villages Children must be aged between 6 and 59 months Children must have moderate anemia (7 - 10g/dl) Children with chronic or acute disease Children with sickle-cell anemia or consume multi-vitamin-mineral supplements on a regular basis 6 Month(s) 5 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 08/06/2015 National Instute of Medical Research (NIMR)
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar-es-salaam 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemoglobin level Baseline Middle End of intervention (Six months)
Primary Outcome Vitamin A levels Baseline End of intervention (Six months)
Primary Outcome Nutritional Status Baseline End of intervention (Six months)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oturumeti Arusha DC Arusha +255 Tanzania
Oldonyosambu Arusha DC Arusha +255 Tanzania
Seliani Arusha DC Arusha +255 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
COSTECH Kinondoni Dar-es-salaam +255 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Nelson Mandela African Institution of Science and Technology Meru Arusha +255 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Dr. Martin E. Kimanya Arusha Arusha +255 Tanzania
Prof. Theobald C. Mosha Morogoro Morogoro +255 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dyness Kejo kejod@nm-aist.ac.tz +2557596284 Tengeru
City Postal code Country Position/Affiliation
Arusha +255 Tanzania Student
Role Name Email Phone Street address
Principal Investigator Dyness Kejo kejod@nm-aist.ac.tz +255767596284 Tengeru
City Postal code Country Position/Affiliation
Arusha 1253 Tanzania Student
Role Name Email Phone Street address
Public Enquiries Martin Kimanya Martinkimanya@nm-aist.ac.tz +255754317687 Arusha
City Postal code Country Position/Affiliation
Arusha Tanzania Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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