Evidence map›Paper›PMID 38685109›Full record

ArticleTrials2024

Adherence and acceptability of multiple micronutrient supplementation during pregnancy: Study protocol for a cluster-randomized non-inferiority trial in Cambodia.

Mai-Anh Hoang, Hou Kroeun, Rolf Klemm, Aman Sen Gupta, Ngik Rem, Sokchea Meng, Sophonneary Prak, Kim Rattana, Mary Chea, Crystal D Karakochuk and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05867836 (Trial of Adherence and Acceptance of Multiple Micronutrient Supplementation), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05867836 nacompletednot on this map

Trial of Adherence and Acceptance of Multiple Micronutrient Supplementation (MMS) vs Iron and Folic Acid (IFA) Among Pregnant Women and Health System Enablers and Constraints Related to MMS in Cambodia

TypeinterventionalSponsorUniversity of British ColumbiaRan2023 to 2024Enrolled1,545ConditionsPregnancy Related, Antenatal Care, Iron Folic Acid SupplementationArmsIFA vs. MMS during pregnancy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Mai-Anh HoangHelen Keller Intl, Asia Pacific, Manila, Philippines.
Hou KroeunHelen Keller Intl, Cambodia Country Office, Phnom Penh, Cambodia. hkroeun@hki.org.
Rolf KlemmDivision of Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Aman Sen GuptaHelen Keller Intl, Asia Pacific, Manila, Philippines.
Ngik RemHelen Keller Intl, Cambodia Country Office, Phnom Penh, Cambodia.
Sokchea MengHelen Keller Intl, Cambodia Country Office, Phnom Penh, Cambodia.
Sophonneary PrakMinistry of Health, Phnom Penh, Cambodia.
Kim RattanaMinistry of Health, Phnom Penh, Cambodia.
Mary CheaMinistry of Health, Phnom Penh, Cambodia.
Crystal D KarakochukFood, Nutrition and Health, The University of British Columbia, Vancouver, British Colombia, Canada.
Cassandra SauerFood, Nutrition and Health, The University of British Columbia, Vancouver, British Colombia, Canada.
Ashutosh MishraVitamin Angel Alliance, Goleta, CA, USA.
Diwakar MohanDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Meredith Jackson de-GraffenriedHelen Keller Intl, Asia Pacific, Manila, Philippines.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has found benefits of a multiple micronutrient supplement (MMS) over just IFA alone on several outcomes of perinatal and infant health. The Ministry of Health in Cambodia has proposed a transition from IFA to MMS but to effectively guide this transition requires implementation research on the acceptability and adherence to MMS (over IFA).

methodsThis non-inferiority trial aims to assess the adherence and acceptability of IFA (60 mg elemental iron and 400 μg folic acid) compared to MMS (standard UNIMMAP formulation including 15 micronutrients) during antenatal care in Cambodia. A prospective cohort of 1545 pregnant women will be assigned to one of three trial arms: (1) IFA for 90 days [IFA-90]; (2) MMS for 180 days with two distributions of 90-count tablet bottles [MMS-90]; or (3) MMS for 180 days with one 180-count tablet bottle [MMS-180]. Each arm will enroll 515 women across 48 health centers (clusters) in Kampong Thom Province in Cambodia. The primary outcome is the non-inferiority of adherence rates of MMS-180 compared to IFA-90, as assessed by tablet counts. Mixed-effects logistic and linear regression models will be used to estimate the difference in the adherence rate between the two groups, with an 'a priori' determined non-inferiority margin of 15%. Acceptability of MMS and IFA will be measured using a quantitative survey conducted with enrolled pregnant women at 30-day, 90-day, and 180-day time-points. DISCUSSION: Findings from this study will guide an effective and feasible MMS scale-up strategy for Cambodia. Additionally, the findings will be shared globally with other stakeholders planning to scale up MMS in other countries.

trial registrationNCT05867836 ( ClinicalTrials.gov , registered May 18, 2023).

Indexed as

Dietary SupplementsFolic AcidMicronutrientsAdultCambodiaEquivalence Trials as TopicFemaleHumansIronMedication AdherenceMulticenter Studies as TopicPatient Acceptance of Health CarePregnancyPrenatal CareProspective StudiesRandomized Controlled Trials as TopicFolic AcidIronMicronutrientsAcceptabilityAdherenceAntenatalCambodiaIron and folic acidMultiple micronutrientsNon-inferiority trialPregnancySupplementation

Identifiers

PMID38685109
PMCPMC11057137

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.