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临床试验/CTRI/2025/03/081663
CTRI/2025/03/081663尚未招募不适用

Exploring the Interplay Between Micronutrients in Human Milk and Infant Growth in the Indian Population

MICRONUTRIENT FORUM1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Association between micronutrients in human milk with infant growth

研究概览

简要总结

Background: The present study examines the relationship between micronutrient concentrations in human milk (HM) and infant growth in Indian population. Because, there is limited data on how HM micronutrients influence infant health and development, where most studies have been small-scale or short-term.

Rationale and Purpose: SThe micronutrient deficiency in maternal diet raises concerns about the potential impact on breastmilkof exclusively breastfed infants and a plausible link between milk nutrient levels and itseffects on infant health and developmental outcomes. Despite these insights, the precise influence ofHM micronutrients on infant growth remains insufficiently explored. Maternal nutrition directly affects the levels of essential micronutrients in HM, including vitamins and minerals, which may impact infant growth. However, there is a lack of comprehensive longitudinal studies that analyse these micronutrients and their combined effects on infant health. We intend to analysis of the concentrations of micronutrients such as minerals, present in human milk. The HM samples were previously collected and stored as a part of the Human Milk & Infant Nutrition (HMIN)longitudinal study which was a sun study of a larger trial of Intrapartum Azithromycin to prevent sepsis in mothers that concluded in November 2022.

Objectives:(i) To determine the composition of mineral micronutrients concentration in human milkwith a longitudinal sampling at 1 week, 3 months and 6 months timepoints, (ii) To study the association of mineral micronutrients with infant growth

Methods: The study will analyse three hundred HM samples,previously collected from the participants in the HMIN study, for concentration of minerals such as zinc (Zn), magnesium (Mg), calcium (Ca), selenium (Se), mercury (Hg), and lead (Pb).

Study Duration:  One year (The study started February 2024 and will end February 2025)

Expected Outcomes:(i) A mineral micronutrient dataset would be created to provide valuable insights into the nutritional profile of human milk among the Indian sub-population. (ii) Inform on the correlations between mineral micronutrient levels at various time points and respective infant growth trajectories.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Human milk samples collected at 1 week, 3 months and 6 months time points,.

排除标准

  • Non Viable Samples
  • Samples other than human milk.

结局指标

主要结局

Association between micronutrients in human milk with infant growth

时间窗: Endline

次要结局

  • Addresses the prevailing gap in robust data & insights into Human Milk micronutrient levels of breastmilk, particularly in the Indian context(Endline)

研究者

发起方
MICRONUTRIENT FORUM
申办方类型
Other [central platform for evidence and advocacy to improve micronutrient health]
责任方
Principal Investigator
主要研究者

Dr Shilpa Bhaise

Lata Medical Research Foundation

研究点 (1)

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