The SickKids-led research team is currently developing a prenatal micronutrient powder that will contain calcium, iron, and folic acid with different absorption characteristics. Once the powder is developed, it can be incorporated into various oral delivery vehicles. The overall effectiveness of a micronutrient program is highly dependent on the acceptance and regular consumption of supplements (i.e., adherence) by the targeted users. This is a study of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the innovative prenatal multiple micronutrient supplement: traditional tablets, oral disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study hypothesizes that that the formulation of the delivery vehicle will impact preference, acceptability, and palatability.
Study Type
OBSERVATIONAL
Enrollment
149
The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.
Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.
The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.
The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.
International Center for Diarrheal Disease Research
Dhaka, Bangladesh
The Hospital for Sick Children
Toronto, Ontario, Canada
Frequency of Consumption of the Calcium Vehicle
Consumption of the delivery vehicles will be measured during the once-weekly interactions with the research assistants in two ways: (1) by self-report from study participants; and (2) by counting the number of missing doses from those provided in the weekly supply.
Time frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22
Acceptability
Measured by colour, preparation, administration.
Time frame: Day 1, Day 9, Day 16, Day 22
Ease of Use
Measured by size and ease of swallowing.
Time frame: Day 1, Day 9, Day 16, Day 22
Patibility
Measured by taste, texture, aftertaste, and odour.
Time frame: Day 1, Day 9, Day 16, Day 22
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