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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,372
- 试验地点
- 1
- 主要终点
- Change in vitamin A status among children 2-5 years
研究概览
简要总结
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by most households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products.
Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on:
- Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
- Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention
Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes:
- a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or
- a control cube containing iodine only
Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The two study groups will receive different bouillon formulations in packaging that is identical except for the study group code. Linkage between the study group codes and bouillon formulations will be known only to the bouillon producer and independent codekeepers, and not to the investigators, data collection staff, or participants.
入排标准
- 年龄范围
- 2 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •at recruitment (home visit):
- •Inclusion criteria:
- •- Head of household provides oral consent for the participation of household members (index participants), and willingness to have study-provided bouillon cubes used in their household for the next 10 months.
- •Exclusion criteria:
- •Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
- •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.
- •Non-pregnant, non-lactating women of reproductive age
- •Inclusion criteria:
- •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.
- •Exclusion criteria:
- •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;
- •Unable to provide informed consent due to impaired decision-making abilities.
- •Children 2-5 years of age (24-59 mo)
- •Inclusion criteria:
- •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.
- •Exclusion criteria:
- •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];
- •Mid-upper arm circumference < 11.5 cm;
- •Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status.
- •Lactating women
- •Inclusion criteria:
- •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.
- •Exclusion criteria:
- •Pregnancy (determined by self-report);
- •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;
- •Unable to provide informed consent due to impaired decision-making abilities.
- •Exclusion criteria at screening visit for vitamin A isotope dose (WRA only):
- •Non-pregnant, non-lactating women of reproductive age
- •Hemoglobin < 80 g/L at baseline screening visit;
- 另有 35 项未显示
研究组 & 干预措施
Multiple micronutrient-fortified bouillon cube
10-gram shrimp-flavoured bouillon cube, fortified with 6 micronutrients
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
干预措施: Multiple micronutrient-fortified bouillon cube (Dietary Supplement)
Control bouillon cube (iodine only)
10-gram shrimp-flavoured bouillon cube, fortified with iodine
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
干预措施: Control bouillon cube (iodine-only) (Dietary Supplement)
结局指标
主要结局
Change in vitamin A status among children 2-5 years
时间窗: 38 weeks
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Change in vitamin A status among lactating women 4-18 mo postpartum
时间窗: 12 weeks
Breast milk vitamin A concentration and vitamin A per gram fat, measured at baseline and endline
Change in hemoglobin concentration among non-pregnant, non-lactating women
时间窗: 38 weeks
Hemoglobin concentration measured in venous blood at baseline and endline
Change in hemoglobin concentration among children 2-5 years
时间窗: 38 weeks
Hemoglobin concentration measured in venous blood at baseline and endline
Change in zinc status among children 2-5 years
时间窗: 38 weeks
Plasma zinc measured at baseline and endline
Change in folate status among children 2-5 years
时间窗: 38 weeks
Plasma folate concentrations, measured at baseline and endline
Change in vitamin B12 status among non-pregnant, non-lactating women
时间窗: 38 weeks
Plasma vitamin B12 concentrations, measured at baseline and endline
Change in vitamin B12 status among lactating women 4-18 months postpartum
时间窗: 12 weeks
Breast milk vitamin B12 concentrations, measured at baseline and endline
Change in vitamin A status among non-pregnant, non-lactating women
时间窗: 38 weeks
Total body vitamin A stores and estimated liver vitamin A concentration measured by retinol isotope dilution at baseline and endline
Change in iron status among non-pregnant, non-lactating women
时间窗: 38 weeks
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in iron status among children 2-5 years
时间窗: 38 weeks
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in folate status among non-pregnant, non-lactating women
时间窗: 38 weeks
Erythrocyte folate concentrations, calculated from whole blood folate and serum folate concentrations, measured at baseline and endline
Change in zinc status among non-pregnant, non-lactating women
时间窗: 38 weeks
Plasma zinc measured at baseline and endline
Change in vitamin B12 status among children 2-5 years
时间窗: 38 weeks
Plasma vitamin B12 concentrations, measured at baseline and endline
次要结局
- Change in vitamin A status markers among non-pregnant, non-lactating women(38 weeks)
- Change in iodine status among non-pregnant, non-lactating women(38 weeks)
- Change in low milk nutrient concentrations among lactating women 4-18 months postpartum(12 weeks)
- Average daily household consumption of bouillon(38 weeks)
- Adherence to study-provided bouillon(38 weeks)
- Morbidity among children 2-5 years(38 weeks)
- Change in dietary intake among children 2-5 years(38 weeks)
- Change in inflammation among non-pregnant, non-lactating women(38 weeks)
- Morbidity among non-pregnant, non-lactating women(38 weeks)
- Change in cognitive development among children 2-5 years(38 weeks)
- Change in serum folate concentration among non-pregnant, non-lactating women(38 weeks)
- Change in plasma retinol concentration among children 2-5 years(38 weeks)
- Change in iodine status among children 2-5 years(38 weeks)
- Change in iodine status among lactating women 4-18 months postpartum(12 weeks)
- Change in urinary sodium concentrations among non-pregnant, non-lactating women(38 weeks)
- Change in current or recent malaria among non-pregnant, non-lactating women(38 weeks)
- Change in inflammation among children 2-5 years(38 weeks)
- Change in current or recent malaria among children 2-5 years(38 weeks)
- Morbidity among lactating women 4-18 months postpartum(12 weeks)
- Change in dietary intake among non-pregnant, non-lactating women(38 weeks)
- Dietary intake among lactating women 4-18 months postpartum(4 weeks)
- Change in anemia among non-pregnant, non-lactating women(38 weeks)
- Change in micronutrient deficiency among non-pregnant, non-lactating women(38 weeks)
- Change in faecal calprotectin concentrations among children 2-5 years(38 weeks)
- Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years(38 weeks)
- Change in anemia among children 2-5 years(38 weeks)
- Systolic and diastolic blood pressure among non-pregnant, non-lactating women(38 weeks)
- Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years(38 weeks)
- Change in micronutrient deficiency among children 2-5 years(38 weeks)
- Hypertension among non-pregnant, non-lactating women(38 weeks)
- Fecal microbiota among children 2-5 years(38 weeks)