Cornell University-Micronutrient Initiative Calcium Supplementation Study (MICA)

Cornell University

Status: Completed

Conditions: Preeclampsia

Treatments: Dietary Supplement: Regimen A calcium and iron/folic acid; Dietary Supplement: Regimen B calcium and iron/folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02238704

P414/01/2013 (Other Identifier)

IRB #: 1205003071

Details and patient eligibility

About

The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.

Full description

This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).

Enrollment: 1,032 patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Attendance at ANC clinic in a primary care facility in Kakamega north

Exclusion criteria

• Gestational age < 16 weeks,
• Gestational age > 30 weeks,
• Dietary or medicinal consumption of adequate calcium (according to the screening survey),
• Intention to leave study community before 8weeks from date of interview

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,032 participants in 2 patient groups

Regimen A

Experimental group

Description:

500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day

Treatment:

Dietary Supplement: Regimen A calcium and iron/folic acid

Regimen B

Active Comparator group

Description:

500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day

Treatment:

Dietary Supplement: Regimen B calcium and iron/folic acid