Last updated on February 2018

Human Milk Composition in Indian Mothers

Brief description of study

Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother. Given the huge diversity noted in nutritional status and ethnic dietary patterns in Indian population, including pregnant and lactating mothers, it can be conceivably predicted to have an influence on milk composition. With the lack of recent literature addressing these, it is vital to understand and update the influence if any, of nutritional status and dietary patterns on nutritional quality of human milk. The proposed Human milk analysis clinical study in Indian mothers is aimed to achieve a more recent and updated database of nutritional profile of Indian mother's milk considering the dietary and regional influences and demographic differences which can play a key role in levels of nutrients in mother's milk. In order to incorporate the varied dietary patterns, milk samples will be collected from mothers recruited from 8 sites across the country and analysed for important nutrient levels.

Detailed Study Description

The study is a 5-month prospective observational cohort study. Approximately 258 mother-infant pairs in 33-42 weeks of pregnancy will be recruited. Eligibility assessment will be done for the mother at enrolment and for the mother-infant pair at delivery. Based on the recorded anthropometric data and BMI (kg/m2) calculated based on the self-reported pre-pregnancy weight or earliest recorded body weight from their first trimester, mothers consenting to the study will be categorized as either well-nourished or malnourished. All study centers will recruit equal number of participants in each group at their respective sites. As per standard of care, mothers will continue to take the prenatal supplement primarily consisting of folic acid, elemental iron, calcium and will be encouraged to breast feed their infants during prenatal visits. Breastfeeding advice normally consists of messages on the benefits of breastfeeding, instructions on early initiation of breastfeeding and proper breastfeeding techniques, and recommendation on exclusive breastfeeding for the first 6 months. Mothers will be provided with a diary to make a note about their supplement intake and the frequency of breastfeeding. The entry of the details will be enquired telephonically (biweekly) and restated during the face follow-up sessions at study visits 3 and 4.

Clinical Study Identifier: NCT03061929

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Rajini Uday, M.D.

MS Ramaiah Medical College and Hospital
Bangalore, India
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Mala Srivastava, M.D.

Sir Gangaram Hospital
Delhi, India
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Apurba Ghosh, M.D.

Institute of Child Health
Kolkata, India
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Gaurishankar Kamilya, M.D.

Institute of Post Graduate Medical Education & Research and SSKM Hospital
Kolkata, India
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Pradeep Nanjappa, M.D.

Cheluvumba Hospital
Mysore, India
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Umesh Vaidya, M.D.

King Edward Memorial Hospital
Pune, India
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Ashish Dhongade, M.D.

Sant Dnyadneshwar Medical Institute
Pune, India
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S N Singh, M.D.

King George Medical College & University
Uttar Pradesh, India
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