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临床试验/NCT02756026
NCT02756026已完成不适用

Assessing the Quality of Breast Milk

USDA, Western Human Nutrition Research Center1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Change in Breast Milk Content of Cobalamin (Vitamin B12)

研究概览

简要总结

The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. The investigators will determine which breastfeeding episode during the 24 hour period best represents the maternal status; and within the episode whether fore, mid or hind milk samples be collected in future studies.

详细描述

Mother-infant pairs were recruited in the peri urban area of Dhaka, Bangladesh to participate in a protocol development study at International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). The participants will spend 5 days in a metabolic unit of icddr,b and the procedures are as follows:

  • On day 1, mother-infant pairs will come to the facility, consume their evening meal and spend the night.
  • On day 2, the mothers will be asked to breastfeed their infant from one breast for as long as the infant is interested. An electric breast pump will be placed simultaneously on the other breast for a Full Milk (FM) collection. For the duration of the study the same breast will be used for feeding the infant the other breast will be used for the FM collection. Three separate aliquots of fore milk (up to 1 minute), mid (50 mL), and hind (until the breast is empty) milk will be collected by a special funnel attached to the breast pump. A 5 mL aliquot of BM will be removed from each the 3 aliquots for creamatocrit measurement and later vitamin and mineral determinations. The remainder of the pumped breast milk will be pooled and given to the mother to feed to her infant. A fasting blood sample (7 mL) will be obtained by venipuncture to measure maternal MN status. A breakfast meal will be served to the mother after the first feeding and the blood draw. The mother will be asked to refrain from breastfeeding her infant for the next 2-3 hours then the collection procedure will be repeated until the mother goes to sleep at night, and at any time during the night that the mother wakes to feed her infant. The meals for breakfast, lunch and dinner will be low in micronutrients.
  • On day 3, the mothers will be given one commercial multiple micronutrient supplement tablet containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 2. The meals for breakfast, lunch and dinner will be low in micronutrients. Between breast milk collections the staff will collect maternal and infant anthropometry data, and administer Food Frequency (FF) and morbidity questionnaires.
  • On day 4, the mothers will be given two commercial multiple micronutrient supplement tablets containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 3. The meals for breakfast, lunch and dinner will be low in micronutrients.
  • On day 5, the study will end with a final collection of BM in the morning and the study participants will be discharged from the facility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • BMI >18.5 Healthy
  • In the 2nd to 4th month of lactation and breastfeeding ≥12 times/d
  • Breast-feeding only one infant
  • Non-pregnant
  • Willing to spend 4 days and nights at the metabolic unit
  • Willing to perform the procedures of BM collection using the breast pump.

排除标准

  • Severe anemia (Hb <90 g/L) by HemoCue
  • Currently taking micronutrient supplements
  • Current pregnancy
  • Current illness
  • Current Mastitis

结局指标

主要结局

Change in Breast Milk Content of Cobalamin (Vitamin B12)

时间窗: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk

Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay

次要结局

  • Plasma Folate(Measured once in a fasting blood sample collected on day 2)
  • Change in Breast Milk Content of Vitamin A(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of Thiamin(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of Riboflavin(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of Niacin(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of Vitamin B6(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of Vitamin E(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Change in Breast Milk Content of fat(Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk)
  • Plasma Cobalamin (Vitamin B12)(Measured once in a fasting blood sample collected on day 2)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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