(OR38-06-24) Assessing the Adherence to Iron and Folic Acid vs. Multiple Micronutrient Supplements During Pregnancy: A Cluster Randomized Non-Inferiority Trial in Cambodia

Tuesday, July 2, 2024

11:00 AM – 11:12 AM CT

Location: W375A

Presenting Author(s)

CS

Cassandra Sauer, BS

Graduate Student
University of British Columbia
Langley, British Columbia, Canada

Disclosure(s): No relevant financial relationship(s) with ineligible companies to disclose.

Co-Author(s)

MH

Mai-Anh Hoang

Helen Keller International, Philippines
HK

Hou Kroeun, MPH

Deputy Country Director
Helen Keller International
Phnom Penh, Phnom Penh, Cambodia
AS

Aman Sen Gupta, M.Sc.

Hellen Keller International
Lalitpur, Bagmati, Nepal
NR

Ngik Rem

Helen Keller International, Cambodia
SM

Sokchea Meng

Helen Keller International, Cambodia
JL

Jocelyne Labonté

University of Ottawa, Canada
KR

Kim Rattana

Ministry of Health, Cambodia
MC

Mary Chea, MD

Ministry of Health
Phnom Penh, Phnom Penh, Cambodia
RK

Rolf Klemm, Dr PH

Vice President for Nutrition
Helen Keller International
Baltimore, Maryland, United States
AM

Ashutosh Mishra

Vitamin Angel Alliance, India
AP

Aishwarya Panicker

Vitamin Angel Alliance, India
SV

Sokhal Vin

Vitamin Angel Alliance, Cambodia
CK

Crystal D. Karakochuk, PhD (Human Nutrition) (she/her/hers)

Assistant Professor
University of British Columbia
Vancouver, British Columbia, Canada

Objectives: Guidelines in Cambodia recommend iron and folic acid (IFA) supplementation during pregnancy. However, recent research has proven the superiority of multiple micronutrient supplementation (MMS) over IFA to reduce the risk of maternal anemia and adverse birth outcomes. The Cambodian Ministry of Health has expressed strong interest to transition from IFA to MMS during pregnancy but are seeking evidence in the Cambodian context to rigorously inform this policy change. Our primary objective was to assess adherence to MMS vs. IFA supplementation during pregnancy in Cambodia, as one of the first steps.

Methods: We conducted a cluster-randomized non-inferiority trial across 48 health centers in Kampong Thom province. A total of 1,546 pregnant women were recruited at their first antenatal care visit and randomized to one of three arms at the health center-level:

1. IFA for 90 days (IFA-90, n=515), the current standard of care.
2. MMS for 180 days via one 180 tablet bottle (MMS-180, n=516).
3. MMS for 180 days via two 90-tablet bottles (MMS-90, n=515).

The primary outcome was the non-inferiority of adherence rates to MMS-180 (180 days) compared to IFA-90 (90 days), assessed by tablet counts. Mixed-effects linear regression models were used to estimate the mean difference (95% CI) in adherence rates, controlling for health centers (clusters) and using an “a priori’ non-inferiority margin of 15%.

Results: Overall, 87% of women completed the trial, with similar rates across IFA-90, MMS-180 and MMS-90 groups (89%, 88%, and 86% respectively). At enrollment, mean±SD age of women was 28±6 years and gestational age was 8±3 weeks. Overall, mean (95%CI) adherence rates groups were 91% (90, 92), 95% (94, 96), and 95% (94, 96), respectively; adherence was higher in both MMS groups as compared to IFA-90 (P < 0.001). The adjusted mean (95%CI) difference in adherence rates between MMS-180 and IFA-90 groups was 3.5% (1.3, 5.6), and between MMS-180 and MMS-90 groups was 0.3% (-2.5, 1.9).

Conclusions: Adherence to MMS-180 during pregnancy was non-inferior to IFA-90; in fact, MMS-180 showed superiority to IFA-90. Adherence rates in the MMS groups did not differ when tablets were distributed via one vs. two bottles. These findings support the policy change for the use of MMS during pregnancy in Cambodia.

Funding Sources: Vitamin Angel Alliance