Anemia, Iron-DeficiencySumadhurNCT06810440
Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention
A study testing Sumadhur and Multiple micronutrient supplement MMS in people with Anemia, Iron-Deficiency and Nutritional Deficiencies, run by University of California, San Francisco at 1 site in Nepal.
Trial summary
Preconception micronutrient status (including anemia) is a critical determinant of maternal, newborn, and child health that remains undervalued in Nepal. However, providing micronutrient supplements (MMS) alone is not enough. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-Deficiency, Nutritional Deficiencies, Adherence
- What is being tested?
- Sumadhur and Multiple micronutrient supplement MMS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteNepal
- Study dates
- 8 Oct 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- the newly married couple having been married in the last four months
- women being under 25 years old
- never pregnant and not currently pregnant
- co-residing with the mother-in-law in a household as defined by sharing meals together.
- all triad-household members must also be willing to participate
- husbands must not be planning to migrate in the next 6 months.
Who cannot join
- Over 25, under 18 years old
- Currently or ever pregnant
- married more than 4 months before
- not co-residing
- not being willing to participate.
- do not consent to blood-draws
- women who are severely anemic (hemoglobin < 8.0 g/dL) at baseline based on hemoglobin via Hemocue assessment of a fingerprick blood sample at the time of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
Center for Research on Environment, Health and Population Activities (CREHPA)
Kathmandu
Mahesh Puri, PhD, +9779851089910, mahesh@crehpa.org.np
Mahesh Puri, PhD
About this study
Official title: Reducing Anemia Among Young Preconception Women in Nepal Through a Group Household Norm and Micronutrient Supplementation Intervention
Preconception micronutrient status (including anemia) is a critical determinant of maternal, newborn, and child health that remains undervalued in Nepal. However, providing micronutrient supplements (MMS) alone is not enough. In the Nepali context, the gap between marriage and the first birth is short and newly married women have the lowest household status. Addressing the intersectional barriers to health for newly married women, including inequitable gender norms and women's empowerment, household relationships, nutrition knowledge and practices-is essential for improving maternal and infant outcomes in Nepal. To mitigate the community, household, and individual factors resulting in poor nutrition, the team developed and pilot-tested an educational group intervention (Sumadhur, meaning "Best Relationship") for newly married women, husbands, and mothers-in-law triads. Sumadhur aims to provide information on nutrition and women's health, address inequitable gender norms and practices, strengthen household relationships and communication, and improve the household status of newly married women. The pilot study of Sumadhur brought triads of several households together for 16 interrelated sessions over four-months. Findings suggest that participants (N=90) found the intervention to be highly feasible and acceptable and nutritional norms and practices improved.
We propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster RCT (cRCT). The intervention participants will receive the Sumadhur group intervention and will be provided MMS directly at group sessions. In control villages who do not receive the Sumadhur group intervention, we will facilitate access to MMS at primary health centers. We will randomize 70 villages to each arm (with one group per village). Each village has one group of five women (total of 700 women). Newly married women, their husbands and mothers-in-laws (total=2,100), will be followed four times for 18 months post-intervention through surveys, hemoglobin tests and blood draws (women only). The specific aims are to estimate the effectiveness of Sumadhur on women's anemia and micronutrient status, including the cost-benefit of the intervention (Aim 1); explore the impact on intermediate outcomes such as gender norms, household relationships and eating practices and characterize the individual and household-level mechanisms of impact (Aim 2); understand triadic experiences and impact over time of Sumadhur (Aim 3).
Accomplishing these aims will provide evidence for how to improve micronutrient and anemia status among women before they become pregnant-thereby ensuring that women are not deficient in the critical early phases of pregnancy. These findings will also advance the field by testing novel approaches (household and community level behavior and norm change intervention) that, when combined with supplements, may lead to better adherence, uptake, and, ultimately, health outcomes, and have additional longer-term benefits.
Read the detailed description
Anemia and micronutrient (iron, folate, B12, zinc) deficiencies during pregnancy are a leading cause of maternal mortality and morbidity in South Asia and have intergenerational effects, contributing to low birth weight, preterm birth and perinatal mortality. Despite national efforts to provide iron-folic acid (IFA) supplements to pregnant women in Nepal for free, only 41% consume the recommended amount, and high levels of maternal anemia (52%) and micronutrient deficiencies persist. Provision of micronutrient supplements is necessary but not sufficient-intersectional social and behavioral factors also must be addressed. Furthermore, micronutrient status needs to be improved during the preconception period to impact the important first trimester (before most women in Nepal typically seek care) to improve maternal and infant outcomes to the greatest extent possible. With short gaps between marriage and first pregnancy, newly married women should be a focal population. National health and nutrition programs do not currently provide micronutrient supplementation (MMS) to preconception women nor do they mitigate the structural, social, and behavioral (ecological) factors.
Several barriers to adequate nutrition and potential uptake of MMS have been identified. Inequitable gender norms limit women's access to nutrition and health care in South Asia, where women, especially young and newly married, have low levels of empowerment. Women's limited agency in the household and community lead women to have poor dietary diversity, low consumption of micronutrient-rich foods and seek antenatal care late. Household food insecurity and incomplete nutrition knowledge also contribute to women's poor nutritional status preconception and in pregnancy. Hence, engaging other household members (husbands and in-laws) and addressing broader issues around women's status are key to reducing anemia and improving micronutrient status. To address these barriers, interventions engaging multiple household members are necessary to shift norms and promote healthy behavior change, in addition to providing information and access to MMS. Formative research in rural Nepal (K01HD086281) found that newly married women, their husbands, and mothers-in-law ("triads") desired information about nutrition and maternal health. Investigators found that young (<25 years) newly married women often ate last and had low dietary diversity, and positive household relationships were associated with enhanced access to nutritious foods. Thus, in collaboration with local community partners, the investigators developed Sumadhur, a 4-month group intervention that covers preconception and pregnancy nutrition, household eating patterns, anemia, maternal healthcare seeking, gender norms and inequality, and couples/household relationship dynamics. Triads met weekly with other triads (5 households per group=15 people per group). Pilot data from six groups (N=90 participants) found Sumadhur to be acceptable and feasible (83% attended >80% of sessions) and showed preliminary evidence of changes in nutrition norms and practices.8 Based on these promising preliminary findings, the investigators propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster randomized controlled trial. Intervention participants will receive the Sumadhur group intervention and be provided MMS directly at group sessions whereas MMS will be freely available at primary health centers in control villages. The investigators will randomize 70 villages to each arm (140 villages total). Each village will have one group of ~5 newly married women, their husbands and mothers-in-laws (N=2,100), who will be followed every 4-6 months for 18-months post-intervention through surveys, hemoglobin assessments and blood draws (women only). The investigators will conduct concurrent in-depth longitudinal qualitative interviews (LQIs) with a sub-set of triads at each data collection time points.
Aim 1: To estimate the effectiveness of Sumadhur on newly married women's anemia and micronutrient deficiency. The primary effectiveness outcomes are the prevalence of anemia (hemoglobin <12g/dL or <11g/dL if pregnant) and deficiencies/insufficiencies in selected micronutrients: iron, zinc, vitamin B12, and folate (1a).
Secondary outcomes include reproductive, pregnancy/maternal and infant health behaviors and outcomes. The investigators will also determine the cost per disability-adjusted life year averted of the intervention to inform scale-up (1b).
Aim 2: To estimate the (a) effectiveness and (b) mechanism of impact of Sumadhur on intermediary outcomes that may be on the causal path to improved anemia and micronutrient status. The primary outcomes for aim 2a are: (1) social and gender norms, (2) women's empowerment, (3) nutrition and maternal health knowledge, and (4) household relationships and eating patterns, using data collected from all members of triads. In 2b, the investigators will delineate the pathways through which Sumadhur operates, including changing intermediary outcomes and MMS adherence using mediation analyses to identify drivers of intervention impact.
Aim 3: Understand triadic experiences and impact over time of Sumadhur. Using a convergent parallel analysis design, the investigators will uncover explanations for these quantitative findings from multiple perspectives using triadic longitudinal IDI data from newly married women, their husbands, and mothers-in-law.
The investigators' findings will inform programs and policies aiming to reduce anemia and micronutrient deficiencies, which are key contributors to excess maternal, newborn, and child morbidity and mortality globally. This work will lay the groundwork for potential implementation studies of the scale-up and integration into Nepal's National Policy.
- Conditions
- Anemia, Iron-Deficiency, Nutritional Deficiencies, Adherence, Norms, Social, Knowledge, Attitudes, Practice
- Being tested
- Sumadhur, Multiple micronutrient supplement MMS
- Medical subject headings
- Anemia, Iron-Deficiency, Malnutrition, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumadhurBehavioural
Sumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group).
Multiple micronutrient supplement MMSDietary supplement
Multiple micronutrient supplement MMS provided in 180 pill bottles
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will receive the standard of care and the intervention at the end of the study period |
| Intervention | Experimental | Sumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group). Intervention participants will also receive multiple micronutritent supplements (MMS) Receives: Behavioral: Sumadhur; Dietary Supplement: Multiple micronutrient supplement MMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Anemia
Participants with hemoglobin <12g/dL or <11g/dL if pregnant will be considered anemic
Measured: 6 months
Participants with deficiencies/insufficiencies in selected micronutrients
Participants with deficiencies in the following micronutrients: iron, vitamin B12, and folate
Measured: 6 months
Secondary outcomes (2)
Body max index
Body Mass Index measured with weight in kilograms over height in cm
Measured: 18 months
Pregnancy status
Self reported pregnancy, measured using date of last menstrual period
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start8 Oct 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Research on Environment, Health and Population Activities
- Responsible party
- Sponsor
- Investigators
- Nadia G Diamond-Smith, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810440
- Sponsor's protocol ID
- R01HD114798
- Other IDs
- R01HD114798
- Acronym
- Sumadhur
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.
PubMed 30873598Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.
PubMed 31134643Morrison J, Giri R, Arjyal A, Kharel C, Harris-Fry H, James P, Baral S, Saville N, Hillman S. Addressing anaemia in pregnancy in rural plains Nepal: A qualitative, formative study. Matern Child Nutr. 2021 Jul;17 Suppl 1(Suppl 1):e13170. doi: 10.1111/mcn.13170.
PubMed 34241951Daru J, Zamora J, Fernandez-Felix BM, Vogel J, Oladapo OT, Morisaki N, Tuncalp O, Torloni MR, Mittal S, Jayaratne K, Lumbiganon P, Togoobaatar G, Thangaratinam S, Khan KS. Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis. Lancet Glob Health. 2018 May;6(5):e548-e554. doi: 10.1016/S2214-109X(18)30078-0. Epub 2018 Mar 20.
PubMed 29571592Rahman MM, Abe SK, Rahman MS, Kanda M, Narita S, Bilano V, Ota E, Gilmour S, Shibuya K. Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis. Am J Clin Nutr. 2016 Feb;103(2):495-504. doi: 10.3945/ajcn.115.107896. Epub 2016 Jan 6.
PubMed 26739036Diamond-Smith N, Puri MC, Borak L, Walker D, Charlebois E, Weiser SD, McDonald CM. Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol. BMJ Open. 2025 Jul 25;15(7):e103488. doi: 10.1136/bmjopen-2025-103488.
PubMed 40713050
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Anemia Among Young Preconception Women in Nepal Through a Group Household Norm and Micronutrient Supplementation Intervention
- ClinicalTrials.gov ID
- NCT06810440
- Acronym / sponsor ID
- Sumadhur / R01HD114798
- Conditions
- Anemia, Iron-Deficiency, Nutritional Deficiencies, Adherence, Norms, Social, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Research on Environment, Health and Population Activities
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preconception micronutrient status (including anemia) is a critical determinant of maternal, newborn, and child health that remains undervalued in Nepal. However, providing micronutrient supplements (MMS) alone is not enough. In the Nepali context, the gap between marriage and the first birth is short and newly married women have the lowest household status. Addressing the intersectional barriers to health for newly married women, including inequitable gender norms and women's empowerment, household relationships, nutrition knowledge and practices-is essential for improving maternal and infant outcomes in Nepal. To mitigate the community, household, and individual factors resulting in poor nutrition, the team developed and pilot-tested an educational group intervention (Sumadhur, meaning "Best Relationship") for newly married women, husbands, and mothers-in-law triads. Sumadhur aims to provide information on nutrition and women's health, address inequitable gender norms and practices, strengthen household relationships and communication, and improve the household status of newly married women. The pilot study of Sumadhur brought triads of several households together for 16 interrelated sessions over four-months. Findings suggest that participants (N=90) found the intervention to be highly feasible and acceptable and nutritional norms and practices improved.
We propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster RCT (cRCT). The intervention participants will receive the Sumadhur group intervention and will be provided MMS directly at group sessions. In control villages who do not receive the Sumadhur group intervention, we will facilitate access to MMS at primary health centers. We will randomize 70 villages to each arm (with one group per village). Each village has one group of five women (total of 700 women). Newly married women, their husbands and mothers-in-laws (total=2,100), will be followed four times for 18 months post-intervention through surveys, hemoglobin tests and blood draws (women only). The specific aims are to estimate the effectiveness of Sumadhur on women's anemia and micronutrient status, including the cost-benefit of the intervention (Aim 1); explore the impact on intermediate outcomes such as gender norms, household relationships and eating practices and characterize the individual and household-level mechanisms of impact (Aim 2); understand triadic experiences and impact over time of Sumadhur (Aim 3).
Accomplishing these aims will provide evidence for how to improve micronutrient and anemia status among women before they become pregnant-thereby ensuring that women are not deficient in the critical early phases of pregnancy. These findings will also advance the field by testing novel approaches (household and community level behavior and norm change intervention) that, when combined with supplements, may lead to better adherence, uptake, and, ultimately, health outcomes, and have additional longer-term benefits.
Detailed description
Anemia and micronutrient (iron, folate, B12, zinc) deficiencies during pregnancy are a leading cause of maternal mortality and morbidity in South Asia and have intergenerational effects, contributing to low birth weight, preterm birth and perinatal mortality. Despite national efforts to provide iron-folic acid (IFA) supplements to pregnant women in Nepal for free, only 41% consume the recommended amount, and high levels of maternal anemia (52%) and micronutrient deficiencies persist. Provision of micronutrient supplements is necessary but not sufficient-intersectional social and behavioral factors also must be addressed. Furthermore, micronutrient status needs to be improved during the preconception period to impact the important first trimester (before most women in Nepal typically seek care) to improve maternal and infant outcomes to the greatest extent possible. With short gaps between marriage and first pregnancy, newly married women should be a focal population. National health and nutrition programs do not currently provide micronutrient supplementation (MMS) to preconception women nor do they mitigate the structural, social, and behavioral (ecological) factors.
Several barriers to adequate nutrition and potential uptake of MMS have been identified. Inequitable gender norms limit women's access to nutrition and health care in South Asia, where women, especially young and newly married, have low levels of empowerment. Women's limited agency in the household and community lead women to have poor dietary diversity, low consumption of micronutrient-rich foods and seek antenatal care late. Household food insecurity and incomplete nutrition knowledge also contribute to women's poor nutritional status preconception and in pregnancy. Hence, engaging other household members (husbands and in-laws) and addressing broader issues around women's status are key to reducing anemia and improving micronutrient status. To address these barriers, interventions engaging multiple household members are necessary to shift norms and promote healthy behavior change, in addition to providing information and access to MMS. Formative research in rural Nepal (K01HD086281) found that newly married women, their husbands, and mothers-in-law ("triads") desired information about nutrition and maternal health. Investigators found that young (<25 years) newly married women often ate last and had low dietary diversity, and positive household relationships were associated with enhanced access to nutritious foods. Thus, in collaboration with local community partners, the investigators developed Sumadhur, a 4-month group intervention that covers preconception and pregnancy nutrition, household eating patterns, anemia, maternal healthcare seeking, gender norms and inequality, and couples/household relationship dynamics. Triads met weekly with other triads (5 households per group=15 people per group). Pilot data from six groups (N=90 participants) found Sumadhur to be acceptable and feasible (83% attended >80% of sessions) and showed preliminary evidence of changes in nutrition norms and practices.8 Based on these promising preliminary findings, the investigators propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster randomized controlled trial. Intervention participants will receive the Sumadhur group intervention and be provided MMS directly at group sessions whereas MMS will be freely available at primary health centers in control villages. The investigators will randomize 70 villages to each arm (140 villages total). Each village will have one group of ~5 newly married women, their husbands and mothers-in-laws (N=2,100), who will be followed every 4-6 months for 18-months post-intervention through surveys, hemoglobin assessments and blood draws (women only). The investigators will conduct concurrent in-depth longitudinal qualitative interviews (LQIs) with a sub-set of triads at each data collection time points.
Aim 1: To estimate the effectiveness of Sumadhur on newly married women's anemia and micronutrient deficiency. The primary effectiveness outcomes are the prevalence of anemia (hemoglobin <12g/dL or <11g/dL if pregnant) and deficiencies/insufficiencies in selected micronutrients: iron, zinc, vitamin B12, and folate (1a).
Secondary outcomes include reproductive, pregnancy/maternal and infant health behaviors and outcomes. The investigators will also determine the cost per disability-adjusted life year averted of the intervention to inform scale-up (1b).
Aim 2: To estimate the (a) effectiveness and (b) mechanism of impact of Sumadhur on intermediary outcomes that may be on the causal path to improved anemia and micronutrient status. The primary outcomes for aim 2a are: (1) social and gender norms, (2) women's empowerment, (3) nutrition and maternal health knowledge, and (4) household relationships and eating patterns, using data collected from all members of triads. In 2b, the investigators will delineate the pathways through which Sumadhur operates, including changing intermediary outcomes and MMS adherence using mediation analyses to identify drivers of intervention impact.
Aim 3: Understand triadic experiences and impact over time of Sumadhur. Using a convergent parallel analysis design, the investigators will uncover explanations for these quantitative findings from multiple perspectives using triadic longitudinal IDI data from newly married women, their husbands, and mothers-in-law.
The investigators' findings will inform programs and policies aiming to reduce anemia and micronutrient deficiencies, which are key contributors to excess maternal, newborn, and child morbidity and mortality globally. This work will lay the groundwork for potential implementation studies of the scale-up and integration into Nepal's National Policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will receive the standard of care and the intervention at the end of the study period |
| Intervention | Experimental | Behavioral: Sumadhur, Dietary Supplement: Multiple micronutrient supplement MMSSumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group). Intervention participants will also receive multiple micronutritent supplements (MMS) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- the newly married couple having been married in the last four months
- women being under 25 years old
- never pregnant and not currently pregnant
- co-residing with the mother-in-law in a household as defined by sharing meals together.
- all triad-household members must also be willing to participate
Key exclusion criteria (7 listed)
- Over 25, under 18 years old
- Currently or ever pregnant
- married more than 4 months before
- not co-residing
- not being willing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SumadhurSumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group). | Behavioural | Intervention |
| Multiple micronutrient supplement MMSMultiple micronutrient supplement MMS provided in 180 pill bottles | Dietary supplement | Intervention |
Primary outcome
Participants with Anemia
Time frame: 6 months
Participants with hemoglobin <12g/dL or <11g/dL if pregnant will be considered anemic
Participants with deficiencies/insufficiencies in selected micronutrients
Time frame: 6 months
Participants with deficiencies in the following micronutrients: iron, vitamin B12, and folate
2 secondary outcomes
Body max index
Time frame: 18 months
Pregnancy status
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 30873598Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.
- Background: PubMed 31134643Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.
- Background: PubMed 34241951Morrison J, Giri R, Arjyal A, Kharel C, Harris-Fry H, James P, Baral S, Saville N, Hillman S. Addressing anaemia in pregnancy in rural plains Nepal: A qualitative, formative study. Matern Child Nutr. 2021 Jul;17 Suppl 1(Suppl 1):e13170. doi: 10.1111/mcn.13170.
- Background: PubMed 29571592Daru J, Zamora J, Fernandez-Felix BM, Vogel J, Oladapo OT, Morisaki N, Tuncalp O, Torloni MR, Mittal S, Jayaratne K, Lumbiganon P, Togoobaatar G, Thangaratinam S, Khan KS. Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis. Lancet Glob Health. 2018 May;6(5):e548-e554. doi: 10.1016/S2214-109X(18)30078-0. Epub 2018 Mar 20.
- Background: PubMed 26739036Rahman MM, Abe SK, Rahman MS, Kanda M, Narita S, Bilano V, Ota E, Gilmour S, Shibuya K. Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis. Am J Clin Nutr. 2016 Feb;103(2):495-504. doi: 10.3945/ajcn.115.107896. Epub 2016 Jan 6.
- Derived from this study: PubMed 40713050Diamond-Smith N, Puri MC, Borak L, Walker D, Charlebois E, Weiser SD, McDonald CM. Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol. BMJ Open. 2025 Jul 25;15(7):e103488. doi: 10.1136/bmjopen-2025-103488.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia G Diamond-Smith, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sumadhur and Multiple micronutrient supplement MMS in people with Anemia, Iron-Deficiency and Nutritional Deficiencies, run by University of California, San Francisco at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia G Diamond-Smith, PhD (510 914 4586, nadia.diamond-smith@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Anemia (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810440, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.