Brief Summary

Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned.

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

2,640

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2024

Geographic Reach

1 country

119 active sites

Status

active not recruiting

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

1.2 years study duration

First Submitted

Initial submission to the registry

March 18, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

July 4, 2024

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

March 18, 2024

Last Update Submit

January 27, 2025

Conditions

Supplementation

Keywords

Multiple Micronutrient SupplementationIron Folic AcidPregnancyLactation

Outcome Measures

Primary Outcomes (2)

Pregnancy supplementation for 180 days: binary
Consumed at least 180 supplement tablets between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister)
Delivery
Pregnancy supplementation for 180 days: continuous
Number of supplements consumed between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister)
Delivery

Secondary Outcomes (6)

Full pregnancy supplementation: binary
Delivery
Full pregnancy supplementation: continuous
Delivery
MMS supplementation for 180 days: Binary
Delivery
MMS supplementation for 180 days: continuous
Delivery
Antenatal Care Utilization: binary
Delivery
+1 more secondary outcomes

Other Outcomes (10)

Pregnancy supplementation for 30 days: binary
30 days post enrollment/pill eligibility
Pregnancy supplementation for 90 days: binary
90 days post enrollment/pill eligibility
Postpartum supplementation for 45 days: binary
45 days post delivery
+7 more other outcomes

Study Arms (3)

IFA-180 (Blister)

ACTIVE COMPARATOR

Drug: Iron Folic Acid Blister

MMS-180 (Blister)

EXPERIMENTAL

Drug: Multiple Micronutrient Supplement Blister

MMS-180 (Bottle)

EXPERIMENTAL

Drug: Multiple Micronutrient Supplement Bottle

Interventions

Multiple Micronutrient Supplement BlisterDRUG

MMS in a blister pack along with related job aids, counselling during ANC, etc.

MMS-180 (Blister)

Multiple Micronutrient Supplement BottleDRUG

MMS in bottles along with related job aids, counselling during ANC, etc.

MMS-180 (Bottle)

Iron Folic Acid BlisterDRUG

Standard of Care - IFA in a blister pack along with related job aids, counselling during ANC, etc.

IFA-180 (Blister)

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

To be eligible for the study, health facilities must meet four criteria:
public/government-run;
either a PHCC or HP at point of randomization;
implement the standard ANC package of care; and
have the top 50% average monthly caseloads for newly enrolled pregnant women (i.e. first ANC) for that specific agro-ecological zone (mountains - at least 5/month; hill - at least 8/month; and terai - at least 15/month) based on health management information system (HMIS) ANC data (July 16, 2021, to July 15, 2022).
To be eligible for the study, pregnant women must meet multiple criteria, at the point of enrollment:
be 18 - 35 completed years of age at health facility enrollment;
not planning to move/migrate for at least nine months after enrollment;
gestational age of at least 12 but not yet 14 weeks at time of health facility enrollment, estimated based on her last menstrual period (LMP) with exact calendar calculation confirmed during visit by enumerator;
pregnancy without any complications; not classified as severe anemic as well as high-risk pregnancy (i.e. not having the following conditions: diabetes, polycystic ovary syndrome, thyroid disease, kidney diseases, fibroids and severe mental/physical conditions that prevent study participation including unable to speak, attend ANC/PNC, take supplements or mental/cognitive impairment);
provides written informed consent to participate in the study; and
agrees to have enumerators visit the home at different data collection points.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (119)

Thada primary health care centre

Arghakhanchi, Lumbini Province, Nepal

Location

Khairapur health post

Bardiyā, Lumbini Province, Nepal

Location

Mathura haridwar health post

Bardiyā, Lumbini Province, Nepal

Location

Motipur health post

Bardiyā, Lumbini Province, Nepal

Location

Neulapur health Post

Bardiyā, Lumbini Province, Nepal

Location

Sanoshree health post

Bardiyā, Lumbini Province, Nepal

Location

Banakatawa primary health care centre

Bānke, Lumbini Province, Nepal

Location

Banakatti health post

Bānke, Lumbini Province, Nepal

Location

Basudevapur health post

Bānke, Lumbini Province, Nepal

Location

Bejapur health post

Bānke, Lumbini Province, Nepal

Location

Belahari health post

Bānke, Lumbini Province, Nepal

Location

Betahani health post

Bānke, Lumbini Province, Nepal

Location

Chisapani health post

Bānke, Lumbini Province, Nepal

Location

Ganapur health post

Bānke, Lumbini Province, Nepal

Location

Gangapur health post

Bānke, Lumbini Province, Nepal

Location

Hirminiya health post

Bānke, Lumbini Province, Nepal

Location

Holiya health post

Bānke, Lumbini Province, Nepal

Location

Indrapur health post

Bānke, Lumbini Province, Nepal

Location

Jaispur health post

Bānke, Lumbini Province, Nepal

Location

Kalaphata health post

Bānke, Lumbini Province, Nepal

Location

Kathkuiya health post

Bānke, Lumbini Province, Nepal

Location

Khajura primary health care centre

Bānke, Lumbini Province, Nepal

Location

Khaskarkado health post

Bānke, Lumbini Province, Nepal

Location

Laxmanpur primary health care centre

Bānke, Lumbini Province, Nepal

Location

Matahiya health post

Bānke, Lumbini Province, Nepal

Location

Narainapur health post

Bānke, Lumbini Province, Nepal

Location

Phattepur health post

Bānke, Lumbini Province, Nepal

Location

Puraina health post

Bānke, Lumbini Province, Nepal

Location

Puraini health post

Bānke, Lumbini Province, Nepal

Location

Rainyapur health post

Bānke, Lumbini Province, Nepal

Location

Saigaun Health Post

Bānke, Lumbini Province, Nepal

Location

Sonpur health post

Bānke, Lumbini Province, Nepal

Location

Titihiriya health post

Bānke, Lumbini Province, Nepal

Location

Udarapur health post

Bānke, Lumbini Province, Nepal

Location

Udayapur health post

Bānke, Lumbini Province, Nepal

Location

Gadhawa Health Post

Dāng, Lumbini Province, Nepal

Location

Hapur Health Post

Dāng, Lumbini Province, Nepal

Location

Lalmatiya Health Post

Dāng, Lumbini Province, Nepal

Location

Laxmipur Health Post

Dāng, Lumbini Province, Nepal

Location

Satbariya Health Post

Dāng, Lumbini Province, Nepal

Location

Shantinagar Health Post

Dāng, Lumbini Province, Nepal

Location

Sisahaniya Health Post

Dāng, Lumbini Province, Nepal

Location

Aama Health Post