Cornell University-Micronutrient Initiative Calcium Supplementation Study

NCT ID: NCT02238704

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1032 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-06-30

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).

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Regimen A

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

Group Type: EXPERIMENTAL

Regimen A calcium and iron/folic acid

Intervention Type: DIETARY_SUPPLEMENT

Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Regimen B

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

Group Type: ACTIVE_COMPARATOR

Regimen B calcium and iron/folic acid

Intervention Type: DIETARY_SUPPLEMENT

Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Interventions

Regimen A calcium and iron/folic acid

Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Intervention Type: DIETARY_SUPPLEMENT

Regimen B calcium and iron/folic acid

Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kenya Ministry of Health

OTHER_GOV

Sponsor Role: collaborator

University of Nairobi

OTHER

Sponsor Role: collaborator

Micronutrient Initiative

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Dickin, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Chebwayi Health centre

Kakamega, , Kenya

Chegulo Health centre

Kakamega, , Kenya

Chevoso Health centre

Kakamega, , Kenya

Chimoi dispensary

Kakamega, , Kenya

Chombeli Health centre

Kakamega, , Kenya

Imbiakhalo Health centre

Kakamega, , Kenya

Kimangeti Health centre

Kakamega, , Kenya

Kuvasali Health centre

Kakamega, , Kenya

Malava district hospital

Kakamega, , Kenya

Manda Health centre

Kakamega, , Kenya

Miting'ongo Health centre

Kakamega, , Kenya

Mugai Health centre

Kakamega, , Kenya

Namagara Health centre

Kakamega, , Kenya

Shamberere Health centre

Kakamega, , Kenya

Shihome Health centre

Kakamega, , Kenya

Shivanga Health centre

Kakamega, , Kenya

Countries

Kenya

References

Martin SL, Wawire V, Ombunda H, Li T, Sklar K, Tzehaie H, Wong A, Pelto GH, Omotayo MO, Chapleau GM, Stoltzfus RJ, Dickin KL. Integrating Calcium Supplementation into Facility-Based Antenatal Care Services in Western Kenya: A Qualitative Process Evaluation to Identify Implementation Barriers and Facilitators. Curr Dev Nutr. 2018 Aug 23;2(11):nzy068. doi: 10.1093/cdn/nzy068. eCollection 2018 Nov.

Reference Type: DERIVED

PMID: 30402593 (View on PubMed)

Omotayo MO, Dickin KL, Pelletier DL, Mwanga EO, Kung'u JK, Stoltzfus RJ. A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya. J Nutr. 2017 Oct;147(10):1986-1991. doi: 10.3945/jn.117.251926. Epub 2017 Sep 6.

Reference Type: DERIVED

PMID: 28878035 (View on PubMed)

Martin SL, Omotayo MO, Pelto GH, Chapleau GM, Stoltzfus RJ, Dickin KL. Adherence-Specific Social Support Enhances Adherence to Calcium Supplementation Regimens among Pregnant Women. J Nutr. 2017 Apr;147(4):688-696. doi: 10.3945/jn.116.242503. Epub 2017 Mar 1.

Reference Type: DERIVED

PMID: 28250195 (View on PubMed)

Other Identifiers

P414/01/2013

Identifier Type: OTHER

Identifier Source: secondary_id

IRB #: 1205003071

Identifier Type: -

Identifier Source: org_study_id