Cornell University-Micronutrient Initiative Calcium Supplementation Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations

Conditions
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Preeclampsia

Intervention / Treatment
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* Dietary Supplement: Regimen A calcium and iron/folic acid
* Dietary Supplement: Regimen B calcium and iron/folic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>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 | Dietary Supplement: Regimen A calcium and iron/folic acid<br>* Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women<br>|
| Active Comparator: Regimen B<br>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 | Dietary Supplement: Regimen B calcium and iron/folic acid<br>* Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of calcium supplement ingested | 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 | 8 weeks after ANC consultation, during which recruitment into the study occurred | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to related recommendations | Adherence to other features of the WHO recommendation (taking supplements with food). | 8 weeks after ANC consultation, during which recruitment into the study occurred | 
| Motivation | Motivation scores extracted from the survey instrument administered at follow up. | 8 weeks after ANC consultation, during which recruitment into the study occurred | 
| Self-efficacy | Self-efficacy scores extracted from the survey instrument administered at follow up. | 8 weeks after ANC consultation, during which recruitment into the study occurred | 
| Satisfaction | Satisfaction scores extracted from the survey instrument administered at follow up. | 8 weeks after ANC consultation, during which recruitment into the study occurred | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of preeclampsia, Adherence, Calcium supplementation, Adherence to calcium supplementation