Delivery Vehicles for Prenatal Calcium Supplementation

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

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 Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Traditional Tablet; Drug: Chewable tablets; Drug: Unflavoured Powder; Drug: Flavoured Powder

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Center for Diarrheal Disease Research
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who are between 13 and 30 weeks pregnant. Participants will be recruited from Shimantik .

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pregnant Women; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; The Sprinkles Global Health Initiative
• Investigators: Principal Investigator: Daniel Roth, MD, The Hospital for Sick Children; Principal Investigator: Stanley Zlotkin, MD, The Hospital for Sick Children

Publications and helpful links

General Publications

• Baxter JA, Roth DE, Al Mahmud A, Ahmed T, Islam M, Zlotkin SH. Tablets are preferred and more acceptable than powdered prenatal calcium supplements among pregnant women in Dhaka, Bangladesh. J Nutr. 2014 Jul;144(7):1106-12. doi: 10.3945/jn.113.188524. Epub 2014 Apr 23.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Calcium; Supplements
• Other Study ID Numbers: 1000032744