Cornell University-Micronutrient Initiative Calcium Supplementation Study
- Conditions
- Preeclampsia
- Interventions
- Dietary Supplement: Regimen B calcium and iron/folic acidDietary Supplement: Regimen A calcium and iron/folic acid
- Registration Number
- NCT02238704
- Lead Sponsor
- Cornell University
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1032
- Attendance at ANC clinic in a primary care facility in Kakamega north
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regimen B Regimen B calcium and iron/folic acid 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 Regimen A Regimen A calcium and iron/folic acid 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
- Primary Outcome Measures
Name Time Method Amount of calcium supplement ingested 8 weeks after ANC consultation, during which recruitment into the study occurred This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation.
\[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)\] X 100
- Secondary Outcome Measures
Name Time Method Motivation 8 weeks after ANC consultation, during which recruitment into the study occurred Motivation scores extracted from the survey instrument administered at follow up.
Adherence to related recommendations 8 weeks after ANC consultation, during which recruitment into the study occurred Adherence to other features of the WHO recommendation (taking supplements with food).
Satisfaction 8 weeks after ANC consultation, during which recruitment into the study occurred Satisfaction scores extracted from the survey instrument administered at follow up.
Self-efficacy 8 weeks after ANC consultation, during which recruitment into the study occurred Self-efficacy scores extracted from the survey instrument administered at follow up.
Trial Locations
- Locations (16)
Chombeli Health centre
🇰🇪Kakamega, Kenya
Imbiakhalo Health centre
🇰🇪Kakamega, Kenya
Chebwayi Health centre
🇰🇪Kakamega, Kenya
Chevoso Health centre
🇰🇪Kakamega, Kenya
Chegulo Health centre
🇰🇪Kakamega, Kenya
Chimoi dispensary
🇰🇪Kakamega, Kenya
Mugai Health centre
🇰🇪Kakamega, Kenya
Manda Health centre
🇰🇪Kakamega, Kenya
Kimangeti Health centre
🇰🇪Kakamega, Kenya
Kuvasali Health centre
🇰🇪Kakamega, Kenya
Shivanga Health centre
🇰🇪Kakamega, Kenya
Malava district hospital
🇰🇪Kakamega, Kenya
Miting'ongo Health centre
🇰🇪Kakamega, Kenya
Namagara Health centre
🇰🇪Kakamega, Kenya
Shamberere Health centre
🇰🇪Kakamega, Kenya
Shihome Health centre
🇰🇪Kakamega, Kenya