Clinical trial NCT01676636: Delivery Vehicles for Prenatal Calcium Supplementation
Official title: Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy
Calcium
Supplements
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Sprinkles Global Health Initiative
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2012-08-31
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are between 13 and 30 weeks pregnant. Participants will be recruited from Shimantik .

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of Consumption of the Calcium Vehicle
timeFrame: Change from Baseline in Consumption of the Calcium Vehicle at day 22
Secondary outcomes:
measure: Acceptability
timeFrame: Day 1, Day 9, Day 16, Day 22
measure: Ease of Use
timeFrame: Day 1, Day 9, Day 16, Day 22
measure: Patibility
timeFrame: Day 1, Day 9, Day 16, Day 22
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Center for Diarrheal Disease Research
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Stanley Zlotkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.