Delivery Vehicles for Prenatal Calcium Supplementation

The Hospital for Sick Children

Status

Completed

Conditions

Pregnancy

Treatments

Drug: Traditional Tablet

Drug: Chewable tablets

Drug: Flavoured Powder

Drug: Unflavoured Powder

Study type

Observational

Funder types

Other

Identifiers

NCT01676636

1000032744

Details and patient eligibility

About

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.

Enrollment

149 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)