Delivery Vehicles for Prenatal Calcium Supplementation

Completed

• Conditions: Pregnancy
• Interventions: Drug: Traditional Tablet; Drug: Chewable tablets; Drug: Unflavoured Powder; Drug: Flavoured Powder

• Registration Number: NCT01676636
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-08-31
• Study Start: 2012-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women	Flavoured Powder	Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
Pregnant Women	Traditional Tablet	Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
Pregnant Women	Unflavoured Powder	Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
Pregnant Women	Chewable tablets	Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.

Primary Outcome Measures

Name	Time	Method
Frequency of Consumption of the Calcium Vehicle	Change from Baseline in Consumption of the Calcium Vehicle at day 22	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	Day 1, Day 9, Day 16, Day 22	Measured by colour, preparation, administration.
Patibility	Day 1, Day 9, Day 16, Day 22	Measured by taste, texture, aftertaste, and odour.
Ease of Use	Day 1, Day 9, Day 16, Day 22	Measured by size and ease of swallowing.

Trial Locations

Locations (2)

International Center for Diarrheal Disease Research; 🇧🇩 Dhaka, Bangladesh

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada