Completed

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

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What is being collected

Drug Data

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+ drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

From 18 to 40 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorThe Hospital for Sick Children
Last updated: April 19, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01676636
Principal SponsorThe Hospital for Sick Children
Last updated: April 19, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

149 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Current residence in Dhaka at a fixed address
Gestational age of 13-30 completed weeks, estimated based on the recalled first day of the last menstrual period (LMP)
Plan to remain in Dhaka for the duration of the study
Pregnant women ages 18 to < 40 years
3 exclusion criteria prevent from participating
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)
Reported complications of current pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

International Center for Diarrheal Disease Research

Dhaka, BangladeshOpen International Center for Diarrheal Disease Research in Google Maps

The Hospital for Sick Children

Toronto, Canada
Completed2 Study Centers