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临床试验/NCT05867836
NCT05867836Enrolling By Invitation不适用

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 1,545 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,545
试验地点
1
主要终点
Adherence (counts)

研究概览

简要总结

Iron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has showed benefit 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 would like to collect some formative research on this first to assess acceptability and adherence to MMS (over IFA) and help guide key messaging, packaging, and practices to guide the transition in Cambodia.

详细描述

Antenatal multiple micronutrient supplementation (MMS) is a potentially cost-effective, scalable approach that can contribute to addressing the persistent challenge of maternal undernutrition, reducing low birth weight, reducing small-for-gestational age births, and potentially reducing preterm birth. A 2019 independent patient (IDP) meta-analysis indicates MMS decreased mortality for female neonates and provided greater reductions in the risk of low birthweight and preterm birth for infants born to undernourished and anemic women. The 2019 Cochrane Review compared the effects of MMS to iron folic acid (IFA) supplementation in another review and meta-analysis and found MMS supplementation was associated with reduced small-for-gestational age births. Operationalizing MMS interventions in different country contexts is urgently needed to improve the health of mothers and children. However, guidelines on antenatal MMS supplementation have yet to be widely adopted into national policies, in part because the WHO guidelines do not reflect recent evidence.

Helen Keller Intl, with support from Vitamin Angels, conducted a landscape analysis of antenatal MMS supplementation in Cambodia to supportive or potentially supportive stakeholders to accelerate MMS uptake and use in Cambodia. During a stakeholder consultation help in September 2021, workshop participants concluded it is an appropriate time to consider the transition from iron folic acid supplementation (IFA) to MMS supplementation. Following this consultation, a multi-stakeholder Steering Committee was formed, consisting of technical and government representatives from a range of disciplines, to oversee and support this transition.

The landscape analysis revealed that key Cambodian stakeholders are open to exploring the feasibility of a transition from IFA to MMS supplementation for pregnant women and identified key operational and implementation research priorities to inform the transition process. One of those questions relates to the acceptability by pregnant women of MMS in terms of packaging, color, ease of consumption, taste, and overall liking.

The landscape analysis also highlighted the need to assess the adherence of MMS vs. IFA supplementation. WHO recommends that all pregnant women receive a standard dose of 30-60 mg iron and 400 µg folic acid beginning as soon as possible during pregnancy. Ideally, women should receive IFA no later than the first trimester of pregnancy, which means taking 180 tablets before delivery. It is important to note that many countries (including Cambodia) aim for women to receive 90 or more tablets during pregnancy. Currently, in Cambodia the government is distributing 90 tablets of IFA to pregnant women attending public antenatal care services. Thus, to transition from 90 tablets of IFA to 180 tablets is not as easy as a pill switch. To ensure pregnant women can receive the full benefits from MMS supplementation, transitioning from IFA to MMS will require pregnant women to come into ANC during their first trimester and adhere to the recommended 180 tablets of MMS throughout their pregnancy.

To date there are no published studies or documentation from Cambodia on pregnant women's acceptability of MMS supplements or adherence to a 180-dosage regimen of MMS. A 2011 study in two provinces in Cambodia found access to antenatal care (ANC), the number of supplements provided, and ANC attendance were the strongest determinants for adherence to IFA supplementation. Another analysis in Cambodia found the primary reasons for not taking the WHO recommended number of 180 IFA doses (WHO, 2012) were starting ANC after the 1st trimester and not attending all recommended ANC visits. In Nepal, researchers have found knowledge about preventable conditions and benefits, perceived barriers, social support, and perceived severity of not taking the supplement predicted IFA compliance while other also found forgetting to take the supplements was a barrier. In a study from Vietnam, determinants of adherence to either folic acid, IFA, or MMS supplementation were socioeconomic status, ethnicity, occupation, and parity, as well as increased contact with health workers. Acceptability studies which included MMS supplementation have identified organoleptic properties perceived benefits, and fears or perceived negative effects as influential factors on acceptance and utilization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-45 years
  • Gestational age less than 14 weeks
  • Low risk pregnancy
  • Live in Kampong Thom and will not move away within the next 6 months
  • Agree to have data collectors come to your home once a month to complete a survey and pill weighing or counting

排除标准

  • Women participating in any nutrition programs beyond the normal care provided though government facilities

结局指标

主要结局

Adherence (counts)

时间窗: 90 days for the IFA-90 group and 180 days for the MMS-180 group

Adherence as per pill count at the final visit

次要结局

  • Adherence (weights)(90 days for the IFA-90 group and 180 days for the MMS-180 group)
  • Acceptability (quantitative)(30 day-, 90 day- and 180-day timepoints)
  • Acceptability (qualitative)(90 days for IFA group and 180 days for MMS-180 group)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal Karakochuk

Assistant Professor, Human Nutrition

University of British Columbia

研究点 (1)

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