Protocol No: ECCT/25/12/01 Date of Protocol: 10-09-2025

Study Title:

Assessing the acceptability of enhanced multiple micronutrient supplements among pregnant women in Bungoma County

 

Study Objectives:

1. To test the organoleptic properties (i.e. taste, smell, texture and color) of the three different MMS formulations (MMS, MMS+ and MMS+).

  •  To assess the first impression and immediately reactions
  • To evaluate the reactions and impression after 2 weeks use

2. To assess the acceptability of the different MMS/MMS+ and MMS++ formulations

3. To explore potential barriers and enablers towards intake MMS/MMS+ and MMS++ supplementation among pregnant women

 

Laymans Summary:

Evidence has shown that using Multiple Micronutrient Supplements is more effective in maternal nutrition and infant outcomes. While we have approved MMS over the years, there is need to review the composition to include other important nutrients for brain development such as choline and DHA. In this regards, Kenya Medical Research Institute (KEMRI), University of Copenhagen (Denmark) and University of Bergen and Innlandet Hospital (Norway) have partnered to design and develop an improved Multiple Micronutrient Supplement under the study “Mother Micronutrient Supplement for Pregnancy and Lactation (MoMS)” project which is currently registered in SERU, KEMRI/SERU No 5217. Because the study team have designed and improved the existing MMS product into three new products, they would like to test the three improved products among the pregnant women to test which of the products will be preferred most based on taste, color, flavor, texture and packaging including the preferred for ease of taking. To correctly test the new products, the study will first recruit pregnant women into three groups and give the supplements at two weeks intervals and then change the product among the groups. During the crossover, women will be allowed one week without taking anything so that there are no effects of the previous product affecting the perceptions of the second product. After 8 weeks of the interventions, the women will be talked to in groups of 8-10 women. All the data collected will be analyzed to understand the differences reported by the different groups of treatment arms but also to listen to the women to understand their thoughts about the products and if there any specific issues of concern the study team should address.

 

Abstract of Study:

Discussions on the benefits of multiple micronutrient supplements (MMS) in pregnancy began in 1999, when the World Health Organization (WHO) recommended the UNIMMAP formulation—comprising 15 essential vitamins and minerals—with a call for further research. Although MMS has shown positive effects on pregnancy and birth outcomes, evidence remains suboptimal. Key questions persist regarding the need to revise the standard UNIMMAP formulation by increasing certain nutrient levels or incorporating additional nutrients to enhance efficacy.

The Mother’s Micronutrient Supplement for Pregnancy and Lactation (MoMS) study aims to address these gaps by developing new MMS formulations that include higher levels of select B vitamins, as well as Choline and DHA. The MoMS project is registered under KEMRI/SERU No. 5217.

Before these new formulations can be tested in a randomized controlled trial, acceptability must be evaluated. The MoMS–Acceptability Testing Study (MoMS-ATS) will use a sequential mixed-methods design, beginning with a quantitative component—a 3x3 randomized non-inferiority cross-over trial—to assess acceptability of three different MMS formulations during pregnancy. This will be followed by qualitative research in Bungoma County, conducted in a separate location from the main study sites. A total of 108 pregnant women will be enrolled and followed for 8 weeks. Three focus group discussions (FGDs) will then be held with 8–10 participants in each group.

Quantitative data will be analyzed using descriptive statistics and appropriate inferential tests, including Chi-square or Fisher’s exact test for categorical variables and suitable tests for continuous variables. Acceptability will be modeled based on organoleptic properties, with significance set at p < 0.05. Qualitative data will be audio-recorded, transcribed verbatim, and analyzed thematically using NVivo or ATLAS. Ti. Triangulation of qualitative and quantitative findings will provide comprehensive insights into supplement acceptability and user preferences.