NCT02238704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

September 5, 2014

Last Update Submit

July 26, 2016

Conditions

Preeclampsia

Keywords

AdherenceCalcium supplementationPrevention of preeclampsiaAdherence to calcium supplementation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Adherence to related recommendations

    8 weeks after ANC consultation, during which recruitment into the study occurred

  • Motivation

    8 weeks after ANC consultation, during which recruitment into the study occurred

  • Self-efficacy

    8 weeks after ANC consultation, during which recruitment into the study occurred

  • Satisfaction

    8 weeks after ANC consultation, during which recruitment into the study occurred

Study Arms (2)

Regimen A

EXPERIMENTAL

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

Regimen B

ACTIVE COMPARATOR

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

Interventions

Regimen A calcium and iron/folic acidDIETARY_SUPPLEMENT

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

Regimen A
Regimen B calcium and iron/folic acidDIETARY_SUPPLEMENT

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

Regimen B

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Chebwayi Health centre

Kakamega, Kenya

Location

Chegulo Health centre

Kakamega, Kenya

Location

Chevoso Health centre

Kakamega, Kenya

Location

Chimoi dispensary

Kakamega, Kenya

Location

Chombeli Health centre

Kakamega, Kenya

Location

Imbiakhalo Health centre

Kakamega, Kenya

Location

Kimangeti Health centre

Kakamega, Kenya

Location

Kuvasali Health centre

Kakamega, Kenya

Location

Malava district hospital

Kakamega, Kenya

Location

Manda Health centre

Kakamega, Kenya

Location

Miting'ongo Health centre

Kakamega, Kenya

Location

Mugai Health centre

Kakamega, Kenya

Location

Namagara Health centre

Kakamega, Kenya

Location

Shamberere Health centre

Kakamega, Kenya

Location

Shihome Health centre

Kakamega, Kenya

Location

Shivanga Health centre

Kakamega, Kenya

Location

Related Publications (3)

  • 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.

    PMID: 30402593DERIVED

  • 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.

    PMID: 28878035DERIVED

  • 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.

    PMID: 28250195DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Katherine Dickin, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 12, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

KE(16)