PACTR202206868437931尚未招募未知
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
niversity of California Davis0 个研究点目标入组 2,408 人开始时间: 2022年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,408
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 Year(s) 至 5 Year(s)（—）
- 性别
- All
入选标准
- •Head of household provides oral consent for participation of household members (index participants), and willingness to have study-provided bouillon used in household cooking for the next 10 months.
- •Non-pregnant non-lactating women of reproductive age (15 - 49 years):
- •Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, assent provided from the index participant and consent from a parent or guardian) ;
- •Planning to remain in the study area for the next 10 months;
- •Willing to use study-provided bouillon in household cooking for the next 10 months;
- •Not planning to become pregnant during the next 10 months.
- •Child 2-5 years of age (24-59 mo);
- •Signed informed consent for the child's participation from a parent or guardian;
- •Planning to remain in the study area for the next 10 months;
- •Caregiver willing to use study-provided bouillon in household cooking for the next 10 months.
- •Lactating women:
- •Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding a child who is 4-18 months of age;
- •Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, provide assent from the index participant and consent from a parent or guardian);
- •Planning to remain in the study area for the next 4 months;
- •Planning to breastfeed for the next 4 months;
- •Willing to use study-provided bouillon in household cooking for the next 4 months;
- •Not planning to become pregnant during the next 4 months.
排除标准
- •Exclusion criteria at recruitment visit:
- •Severe illness warranting immediate hospital referral;
- •COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- •Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- •Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
- •Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
- •Unable to provide informed consent due to impaired decision-making abilities (women only);
- •Current participation of any household member in a clinical trial;
- •Reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusk allergy, or a previous adverse reaction to bouillon by the participant or any member of their household.
- •Mid-upper arm circumference <11.5cm (children 2-5 years only)
- •Pregnancy (determined by self-report)(lactating women only, at recruitment)
- •Note: Field is not large enough to include all exclusion criteria at all time points. Please see clinicaltrials.gov NCT05178407 for complete list.
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