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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607875109856 Date of Registration: 02/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mother’s micronutrient supplementation for pregnancy and lactation: A randomized controlled trial
Official scientific title Effects of enhanced multiple micronutrient supplements on pregnancy and lactation on birthweight, infant growth and neurodevelopment: A randomized double blind controlled trial and pregnancy cohort (MoMS Trial)
Brief summary describing the background and objectives of the trial Background: Micronutrient deficiencies have serious consequences for maternal and child health. Deficiencies during critical periods in utero and early childhood have lasting health and developmental effects throughout the lifespan. There is compelling evidence that providing the standard United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation of 15 micronutrients during pregnancy improves maternal health, birth outcomes, and child health. However, there is substantial uncertainty regarding the optimal composition and doses of the standard multiple micronutrient supplements (MMS) . Notably, the current MMS does not include several key nutrients such as the omega-3 polyunsaturated fatty acid docosahexaenoic acid (DHA), calcium, choline and nicotinamide, that play important roles in fetal and infant growth, neurodevelopment, and metabolic health. Objectives: Primary objective: To evaluate the effects of enhanced multiple micronutrient supplement (MMS++ vs MMS) formulation on birth weight Key secondary objectives: To evaluate the effects of MMS++ vs MMS on lean body mass at birth and 6 months of age, neurodevelopment and weight at 6 months of age. Other secondary objectives: To evaluate the effects of MMS++ vs MMS on several outcomes reflecting health, development and metabolic responses throughout the intervention period. Methods: Randomized controlled superiority trial with 4 arms: MMS, MMS++, MMS+, MMS- (1300:1300:200:200) Study Population: Pregnant women <20 weeks of gestation and their offspring residing in the catchment areas of Bumula and Sirisia, Bungoma County, Kenya. Intervention: (i) DHA, choline, nicotinamide, and increased doses of other B-vitamins (MMS++ (ii) - 4) Comparators: Standard multiple micronutrient supplement (MMS), MMS with lower doses of DHA and choline, increased nicotinamide but standard doses of other B-vitamins (MMS+) and MMS- (iron and folic acid) for the sub study. All groups are given calcium. The pregnant women will be provided a supplement every day throughout pregnancy and 6 months postpartum. All mother-infant pairs, regardless of study intervention, will be included in a pregnancy and birth cohort. Primary endpoint: Birth weight (grams). Key secondary outcomes: 1) Lean body mass at birth and 6 months of age, 2) Neurodevelopment measured by the Global Scales for Early Development at 6 months of age 3) Infant weight at 6 months of age
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MoMS
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Micronutrients - Multiple Micronutrient Supplementation
Anticipated trial start date 01/09/2026
Actual trial start date 30/09/2026
Anticipated date of last follow up 30/09/2028
Actual Last follow-up date 31/12/2029
Anticipated target sample size (number of participants) 3000
Actual target sample size (number of participants) 2700
Recruitment status Not yet recruiting
Publication URL N/A
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MoMS MMS Plus Daily Dose During Pregnancy and through one year of infancy The experimental intervention in the main RCT is 1) MMS plus DHA(400mg), choline(850mg), nicotinamide(118mg) and increased doses of other B vitamins (MMS++) All women will receive one tablet and one energy-dense biscuit per day (28 g/biscuit, package size 18 biscuits). Each 28 g biscuit will provide 109-133 kcal, 2.5-3.2 g protein and 5.8-6.4 g fat per day. The supplements will be consumed 1 x daily from enrolment (< 20 weeks of gestational age (GA)), throughout pregnancy and for 6 months postpartum. It is recommended to take the supplements just before a meal to minimize after taste. Supplements will be distributed for 2 weeks of intake at the time. The women are instructed not to take any other supplements during the study period 1300
Control Group MMS The control group in the main RCT is 1) MMS the standard UNIMMAP supplement for Pregnancy without Choline, or DHA and standard B vitamins. All women will receive one tablet and one energy-dense biscuit per day (28 g/biscuit, package size 18 biscuits). Each 28 g biscuit will provide 109-133 kcal, 2.5-3.2 g protein and 5.8-6.4 g fat per day. The supplements will be consumed 1 x daily from enrolment (< 20 weeks of gestational age (GA)), throughout pregnancy and for 6 months postpartum. It is recommended to take the supplements just before a meal to minimize after taste. Supplements will be distributed for 2 weeks of intake at the time. The women are instructed not to take any other supplements during the study period During Pregnancy and through the first Childs one year MMS 1300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Criteria for inclusion of subjects i. Women of reproductive age (15-49 years) ii. Confirmed pregnancy before 20 weeks of gestation iii. Willing to consent and able to participate for the duration of the study (knowing that it is possible to withdraw from the study at any time) iv. A resident of the area and no plans move away throughout the study period. Criteria for exclusion of subjects i. Known chronic and acute illness including cancer, mental illness, uncontrolled diabetes or disability that impair their ability to participate ii. Gross fetal abnormalities iii. On a different supplementation program iv. Known food allergies relevant to the study intervention Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Infant: 1 Month(s)-12 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month 15 Year(s) 49 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 24/03/2026 KEMRI Scientific Review And Ethics Unit
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Way Nairobi 00200 Kenya
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 11/06/2026 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Way Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Birthweight Monthly
Secondary Outcome • Lean body mass at birth and 6 months of age • Weight at 6 months of age • Neurodevelopment measured by the GSED at 6 months of age Baseline, 6 months, 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Public Health Research Kenya Medical Research Institute Off Hospital Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Gates Foundation 500 5th Ave N, Seattle, WA 98109, USA Seattle Washington United States of America
Novo Nordisk Foundation Novo Alle 2880 Bagsvaerd Copenhagen Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenya Medical Research Institute Off Mbagathi Way Nairobi Kenya Government Institute
COLLABORATORS
Name Street address City Postal code Country
University of Bergen Postboks 7800, 5020 Bergen Norway
University of Copenhagen Norregade 10 1165 Kobenhavn K Copenhagen Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zipporah Bukania zbukania@kemri.go.ke +25722336292 Off Hopsital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Principal Research Scientists
Role Name Email Phone Street address
Scientific Enquiries Tor Strand Tor.Strand@uib.no +4790971086 7800 N 5020 Bergen
City Postal code Country Position/Affiliation
Bergen Norway Proffessor at Centre for International Health
Role Name Email Phone Street address
Public Enquiries Benedikte Grenov bgr@nexs.ku.dk +4520456654 Norre Alle 51 DK 2200
City Postal code Country Position/Affiliation
Copenhagen Denmark Professor at Department off Nutrition and Exercise
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All electronic participant data will be encrypted and kept confidential. Any piece of information is only visible to those given access. Access can only be given by the central system administrators. All staff user access and data entry are restricted by user identification and password. Furthermore, data entry or modifications are logged by the data platform along with the user’s identification. We will securely store the data on safe servers in Kenya. Before the study commences, we will create a comprehensive variable dictionary, including a detailed list of all variables to be collected. The data management plan will outline the process for data sharing and specify the appropriate contacts within the study team for inquiries. Data will be made available for future use through a Data Hub. A separate governance structure will be developed before research data is transferred to this Data Hub. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 24 months with possibility of extension on individual request considerations Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Requests will be requested at least 6 months after publication of the main article of the trial and the access will be for a maximum of 24 hours Data or samples shared will be coded, without personal Identifier information. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 26/06/2026 response to the review comments to include Objectives Background: Micronutrient deficiencies have serious consequences for maternal and child health. Deficiencies during critical periods in utero and early childhood have lasting health and developmental effects throughout the lifespan. There is compelling evidence that providing the standard United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation of 15 micronutrients during pregnancy improves maternal health, birth outcomes, and child health. However, there is substantial uncertainty regarding the optimal composition and doses of the standard multiple micronutrient supplements (MMS) . Notably, the current MMS does not include several key nutrients such as the omega-3 polyunsaturated fatty acid docosahexaenoic acid (DHA), calcium, choline and nicotinamide, that play important roles in fetal and infant growth, neurodevelopment, and metabolic health.Objectives: To measure the effect of two enhanced MMS formulations, MMS + (standard MMS with calcium, DHA, choline and nicotinamide) and MMS++ (MMS+ with higher doses of some B-vitamins) given from early pregnancy until 6 months post-partum on child growth and neurodevelopment compared to standard MMS. Methods: In this double-blind, individually randomized, controlled trial (RCT) we will include 3000 pregnant women from Bungoma County, Western Kenya. Women will be identified from health facilities and included before week 20 of gestation and randomized to 4 different MMS groups. Women will be randomized into 3 groups receiving standard MMS, MMS+ or MMS ++ in a ratio of 1:1:1 (n=3x950=2850). Another 150 women will be randomized to a study arm receiving iron and folic acid (IFA) only. These 150 women a from each of the three other study groups will constitute a mechanistic substudy, with more comprehensive follow-up and assessments. The pregnant women will be provided a supplement every day throughout pregnancy and 6 months postpartum. All mother-infant pairs, regardless of study intervention, will be included in a pregnancy and birth cohort. Outcomes: Primary outcomes of the RCT are infant weight and neurodevelopment measured by the Bayley Scales of Infant Development version 4 at 6 months of age. Key secondary outcomes are birth and neonatal health-outcomes, infant body composition, other neurodevelopmental outcomes, growth using several anthropometric indices, maternal and infant biochemical responses, and responses to childhood vaccines. Expected Application of Results: The proposed RCT will provide causal evidence of the effect of a modified MMS composition for pregnant women that can be generalized beyond the study site. The study will also provide critical knowledge on the relationship between early life exposures, growth, and child development. Background: Micronutrient deficiencies have serious consequences for maternal and child health. Deficiencies during critical periods in utero and early childhood have lasting health and developmental effects throughout the lifespan. There is compelling evidence that providing the standard United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation of 15 micronutrients during pregnancy improves maternal health, birth outcomes, and child health. However, there is substantial uncertainty regarding the optimal composition and doses of the standard multiple micronutrient supplements (MMS) . Notably, the current MMS does not include several key nutrients such as the omega-3 polyunsaturated fatty acid docosahexaenoic acid (DHA), calcium, choline and nicotinamide, that play important roles in fetal and infant growth, neurodevelopment, and metabolic health. Objectives: Primary objective: To evaluate the effects of enhanced multiple micronutrient supplement (MMS++ vs MMS) formulation on birth weight Key secondary objectives: To evaluate the effects of MMS++ vs MMS on lean body mass at birth and 6 months of age, neurodevelopment and weight at 6 months of age. Other secondary objectives: To evaluate the effects of MMS++ vs MMS on several outcomes reflecting health, development and metabolic responses throughout the intervention period. Methods: Randomized controlled superiority trial with 4 arms: MMS, MMS++, MMS+, MMS- (1300:1300:200:200) Study Population: Pregnant women <20 weeks of gestation and their offspring residing in the catchment areas of Bumula and Sirisia, Bungoma County, Kenya. Intervention: (i) DHA, choline, nicotinamide, and increased doses of other B-vitamins (MMS++ (ii) - 4) Comparators: Standard multiple micronutrient supplement (MMS), MMS with lower doses of DHA and choline, increased nicotinamide but standard doses of other B-vitamins (MMS+) and MMS- (iron and folic acid) for the sub study. All groups are given calcium. The pregnant women will be provided a supplement every day throughout pregnancy and 6 months postpartum. All mother-infant pairs, regardless of study intervention, will be included in a pregnancy and birth cohort. Primary endpoint: Birth weight (grams). Key secondary outcomes: 1) Lean body mass at birth and 6 months of age, 2) Neurodevelopment measured by the Global Scales for Early Development at 6 months of age 3) Infant weight at 6 months of age