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.: PACTR202007530633282 Date of Approval: 17/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of an integrated programme to reduce maternal and child malnutrition in Kenya
Official scientific title Effectiveness of an integrated programme to reduce maternal and child malnutrition in Kenya
Brief summary describing the background and objectives of the trial Background: In Kenya, 26% of children under-five years of age are malnourished, and 26% of pre-school children, 26% of women of reproductive age and 42% of pregnant women are anaemic, respectively. Agriculture is the main source of income and food for the majority of rural families in Sub-Saharan Africa including Kenya. Agricultural programmes have led to increased yield and household income but had limited success in improving nutritional status. Objectives: To assess the impact on growth and micronutrient status of an integrated programme by introducing nutrition-specific (e.g. micronutrient supplements) and nutrition-sensitive (improved water, sanitation and hygiene, e.g. chlorine, soap) components to an existing agricultural programme. In order to monitor and assess these objectives, two studies were designed to be conducted in the Western Province of Kenya and are presented here as study 1 and study 2: • Study 1: a cluster-randomized, parallel-group, prospective, follow-up effectiveness study that will span over the "1,000 days window", the period from conception until the child’s second birthday • Study 2: a cluster-randomized, parallel-group, prospective, follow-up effectiveness study in children 6-35 months of age at recruitment that spans over 2 years
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 Nutrition-specific and nutrition-sensitive
Anticipated trial start date 01/06/2018
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 3200
Actual target sample size (number of participants) 3200
Recruitment status Closed to recruitment,follow-up continuing
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition supplements and Agriculture products supported by Nutrition and WASH trainings LNS Enov Mum - 1 20g sachet per day from <20 weeks GA to when child turns 6 months LNS Enov Mum - 1 20g sachet per day from <20 weeks GA to when the child turns 6 months Micronutrient Powders (MNPs)- 1 sachet of 1g every three days for children 6-59 months of age Interventions were given to the treatment arm only. 1600
Experimental Group Nutrition supplements Micronutrient Powders (MNPs)- 1 sachet of 1g every three days 2 years Aims to improve the diet quality of nutritionally vulnerable groups, such as young children. MNPs are dosed into sachets containing the dry powder with micronutrients that can be added to any semi-solid or solid food that is ready for consumption. 1600
Control Group Agriculture training for Study 1 Provide agriculture training once every 2 weeks 2 years Provide agriculture training once every 2 weeks 1600 Active-Treatment of Control Group
Control Group Agriculture Training for study 2 Provide agriculture training once every 2 weeks 2 years Provide agriculture training once every 2 weeks 1600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants fulfilling all of the following inclusion criteria are eligible for the study: Study 1: - Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks - Written Informed Consent as documented by signature Study 2: - Children 6-35 months of age at recruitment - Written Informed Consent as documented by signature Study 1: - If a family does not intend to stay within the study area for at least the following 30 months - Known history of allergy towards peanut or milk products - Visible severe disease Study 2: - A family does not intend to stay within the study area for at least the following 24 months - Visible severe disease Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 0 Day(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 30/01/2020 Amref ESRC
Ethics Committee Address
Street address City Postal code Country
Postal 30125-00100 Nairobi- Off Langata Rd Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome-change in Length for Age Z scores between birth and 24 months of age in study 1 and over the course of the 2 years programme activity in study 2. 2 years
Secondary Outcome Secondary Outcome- Blood-based secondary outcomes measured in children in study 1 include: Haemoglobin concentration measured at birth and 6 and 24 months of age will be used to assess the change in haemoglobin concentration and proportion with anaemia (Hb< 11g/dL). SF (serum ferritin), CRP (C-reactive protein) and AGP (alpha 1- acid glycoprotein) measured at 6 and 24 months of age will be used to assess the proportion with inflammation-adjusted iron deficiency (SF<12 μg/L) and the change in proportion with inflammation-adjusted iron deficiency. RBP (retinol-binding protein), CRP and AGP measured at 6 and 24 months of age will be used to assess the proportion with inflammation-adjusted vitamin A deficiency (RBP<0.7 µmol/L) and the change of proportion with inflammation-adjusted vitamin A deficiency. Blood-based secondary outcomes measured in pregnant women include- Haemoglobin concentration measured at 34 weeks gestation and 6 months postpartum will be used to assess the change in haemoglobin concentration, the proportion with anaemia (Hb < 11 g/dL), and the change in the proportion with anaemia. SF, CRP and AGP measured at 34 weeks gestation will be used to assess the proportion with inflammation-adjusted iron deficiency (SF<15 μg/L). RBP, CRP and AGP measured at 34 weeks gestation will be used to assess the proportion with inflammation-adjusted vitamin A deficiency (RBP<0.7 µmol/L). 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
One Acre Fund Organization Kakamega and Bungoma County of Western Kenya Kakamega 50100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CIFF Children Investment Fund Foundation 7 Clifford Street London, W1S 2FT United Kingdom London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor One Acre Fund Kakamega town- Off Mumias Road Kakamega 50100 Kenya Company
COLLABORATORS
Name Street address City Postal code Country
Rita Wegmuller Phd 7306 Switzerland Hintergass Switzerland
Mr. Kelvin Musau 28777-00100 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rita Wegmuller rita@groundworkhealth.org +41792720203 7306 Switzerland
City Postal code Country Position/Affiliation
Hintergasse Switzerland Principle Investigator
Role Name Email Phone Street address
Public Enquiries Marion Kiprotich mariechep8@gmail.com +254721256437 28777-00100
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya CoPI and liaison officer
Role Name Email Phone Street address
Scientific Enquiries Kelvin Musau kelmusau@gmail.com +254711534867 28777-00100
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Local Principle Investigator and Monitoring Learning and Evaluation Specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Description: Summary results will be posted on this website and on clinicaltrial.org, where the studies have also been registered; further, links to published articles will be placed on these registries. IPD will be made available after de-identification of all datasets through a restricted data sharing platform (e.g. figshare.com or synapse.org). Prior to obtaining de-identified data, interested parties will need to contact the study sponsor with a description of the intended secondary analysis and subsequently, will be requested to sign a data transfer agreement. The main purpose of the data transfer agreement is to ensure data protection is upheld and no attempts will be made to re-identify data, as well as to appropriately acknowledge the original funder and data generators. Informed Consent Form,Study Protocol Data will be released for wider use (see above) one year after primary analysis has been completed (formal ‘breaking’ of treatment allocation codes). The topic of the re-use of data is in context with the initial objectives of the research and as such, has been approved by the various ethical committees; the recipient signs a data transfer agreement confirming fulfillment of the aforementioned aspects.
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