Delivery Vehicles for Prenatal Calcium Supplementation
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.
Drug: Traditional Tablet
Drug: Chewable tablets
Drug: Unflavoured Powder
Drug: Flavoured Powder
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh|
- Frequency of Consumption of the Calcium Vehicle [ Time Frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22 ] [ Designated as safety issue: No ]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.
- Acceptability [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]Measured by colour, preparation, administration.
- Ease of Use [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]Measured by size and ease of swallowing.
- Patibility [ Time Frame: Day 1, Day 9, Day 16, Day 22 ] [ Designated as safety issue: No ]Measured by taste, texture, aftertaste, and odour.
|Study Start Date:||October 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
Drug: Traditional Tablet
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.Drug: Chewable tablets
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.Drug: Unflavoured Powder
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.Drug: Flavoured Powder
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676636
|International Center for Diarrheal Disease Research|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Stanley Zlotkin, MD||The Hospital for Sick Children|
|Principal Investigator:||Daniel Roth, MD||The Hospital for Sick Children|