RELIANCE: Moringa in Lactation and Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Human Milk Production (milk volume)
研究概览
简要总结
This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years.
Women must be >18 years of age, ≤ 21 days postpartum and currently lactating at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk.
After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, 6, 9 and 12 months. Serum from mothers will be collected at recruitment, 2, 4, 6,and 12 months; infant serum will be collected by capillary sample at recruitment and approximately at 2, 6, 12, and 24 months. Infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months.
Dietary recall: the foods and drinks consumed by mothers in the past month prior to each milk sample.
Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.
详细描述
Introduction: The objective of the proposed study is to assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplished by conducting a randomized, controlled, dietary intervention study enrolling 100 breastfeeding mothers and their newborn infants with four months intervention and two years follow up. The propose design is for a study of 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months by breastfeeding mothers of term infants. The investigators will continue the intervention for four months and follow-up for 2 years.
Inclusion Criteria: Women must be >18 years of age; ≤ 21 days postpartum and currently lactating at the time of enrollment. Infants must be at least 36 weeks gestational age at birth, singleton birth, exclusively breastfeeding at the time of enrollment.
Exclusion Criteria: Women who report regular consumption of moringa in the last month (>1 time weekly) or are unable unwilling to lactate are ineligible to participate in this study. Infants are ineligible if born before 37 weeks of gestational age, have significant congenital disease, are unable to feed orally, or unable to consume human milk.
Overall Design: A randomized, controlled dietary intervention trial, titled The MiLC Study: Moringa in Lactation and Early Childhood.
Recruitment and Retention: Potential study participants will be identified on arrival to their first postnatal visit to the SUNY Downstate Maternal and Child Health Clinics. All eligible participants will be offered enrollment. Participants will be screened by trained research assistants and enrolled into the study with individual or caregiver informed consent and monthly check-ins. Participant follow-up will occur concurrent with pediatric monitoring visits (approximately 2, 4, 6, 9, 12, 15, 18, 24 months) for two years utilizing study staff and study equipment. Follow-up not requiring in-person visits or participants who do not arrive to their scheduled study visit will receive phone call/text communication to obtain study information and to reschedule follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 99 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers: Inclusion criteria - >18 years of age, s/p delivery of a healthy infant, and planning breast feeding.
- •Infants: must be born at term (=37-42 weeks), singleton birth, lactating, age 7-21 days at enrollment
排除标准
- •Mothers - women reporting regular consumption of moringa in the last month (>1 time weekly), unable to consume moringa or unable to complete study activities within the first two weeks.
- •Mothers - Women with a contraindication to Moringa use (blood thinners, levothyroxine, antihypertensive treatments, insulin dependency).
- •Infants - significant congenital disease, are unable to feed orally.
研究组 & 干预措施
Carrier and Moringa Leaf Powder
干预措施: Moringa Leaf Powder (Dietary Supplement)
Carrier
干预措施: Carrier (Other)
结局指标
主要结局
Human Milk Production (milk volume)
时间窗: Baseline, 2 months, 4 months, 6 months, 9 months and 12 months
Human milk production measured by 24-hour infant test-weighing to estimate daily milk volume.
Duration of Exclusive Breastfeeding
时间窗: Up to 12 months
Duration of exclusive breastfeeding assessed by maternal report.
次要结局
- Maternal Serum Levels of Estradiol(Baseline, 2 months, 4 months, 6 months and 12 months)
- Maternal Serum Levels of Progesterone(Baseline, 2 months, 4 months, 6 months, and 12 months)
- Maternal Serum Levels of Prolactin(Baseline, 2 months, 4 months, 6 months, and 12 months)
研究者
Philip Kern
Professor
University of Kentucky