Delivery Vehicles for Prenatal Calcium Supplementation

Study Overview
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Brief Summary
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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.

Official Title
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Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Traditional Tablet
* Drug: Chewable tablets
* Drug: Unflavoured Powder
* Drug: Flavoured Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women ages 18 to < 40 years Gestational age of 13-30 completed weeks, estimated based on the recalled first day of the last menstrual period (LMP) Current residence in Dhaka at a fixed address Plan to remain in Dhaka for the duration of the study Exclusion Criteria: Reported complications of current pregnancy Complicated medical or obstetric history that may increase the risk of preterm birth or prenatal complications, based on self-report Moderate or severe anaemia (hemoglobin < 90 g/L, accessed with Hemocue)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>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<br>* 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.<br>Drug: Chewable tablets<br>* 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.<br>Drug: Unflavoured Powder<br>* 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.<br>Drug: Flavoured Powder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline in Consumption of the Calcium Vehicle at day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Measured by colour, preparation, administration. | Day 1, Day 9, Day 16, Day 22 | 
| Ease of Use | Measured by size and ease of swallowing. | Day 1, Day 9, Day 16, Day 22 | 
| Patibility | Measured by taste, texture, aftertaste, and odour. | Day 1, Day 9, Day 16, Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Calcium, Supplements