Human Milk Composition in Indian Mothers

July 2, 2019 updated by: Abbott Nutrition
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560054
        • MS Ramaiah Medical College and Hospital
      • Delhi, India, 110060
        • Sir Gangaram Hospital
      • Kolkata, India, 700017
        • Institute of Child Health
      • Kolkata, India, 700020
        • Institute of Post Graduate Medical Education & Research and SSKM Hospital
      • Lucknow, India, 226003
        • King George Medical College & University
      • Mysore, India, 570021
        • Cheluvumba Hospital
      • Pune, India, 411011
        • King Edward Memorial Hospital
      • Pune, India, 411030
        • Sant Dnyadneshwar Medical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

258 mother-infant pair subjects (86 per group) will be enrolled. The mothers will be normally-nourished or undernourished or over nourished based on pre-pregnancy measured BMI (kg/m2).

Description

Inclusion Criteria:

  1. Mother is at 33 to 42 weeks of pregnancy, is between 20 and 35 years of age and is contactable by telephone
  2. Mother is non smoker and non alcoholic.
  3. Mother has BMI 35 kg per m2 based on self reported pre pregnant weight or the earliest measured weight during the first trimester from the hospital record.
  4. Mother confirms her intention to breast feed for 4 months.
  5. Infant is a singleton with a gestational age of greater than 37 to 42 weeks and is able to feed from the mother normally.
  6. Infants born between 33 to 37 weeks, by definition are preterm, but is not declared very low birth weight by the pediatrician, and is able to feed from the mother normally.
  7. Infant is judged to be in good health in the opinion of the investigator.
  8. Mother or Legally Acceptable Representative has voluntarily signed and dated an Informed Consent Form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion Criteria:

  1. An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential effects on infant's growth and or development. This includes but is not limited to suspected maternal substance abuse such as alcohol or drug.
  2. Mother has known gestational diabetes and/or a diagnosis of pre-eclampsia.
  3. Mother with contraindications to breastfeeding such as known HIV or conditions that can significantly interfere with breastfeeding such as serious illness as per investigator's judgment.
  4. Mother had a breast surgery.
  5. Mother and or newborn infant has major illness that requires intensive care admission 24 hours.
  6. Infant is advised to be kept in NICU and unable to feed from the mother for more than a week or has a medical history that is thought by the investigator to have potential effects on infant's growth and or development.
  7. Infant has major congenital anomaly in the PI's opinion
  8. Participation in another study that has not been approved as a concomitant study by AN.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Undernourised
Mother's with BMI less than 18.5
Normally Nourished
Mother's with BMI greater than or equal to 18.5 to less than or equal to 25.
Overnourished
Mother's with BMI over 25 to less than or equal to 35.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fat content of milk
Time Frame: from 15 days post-partum to 98 days post-partum
Fat content will be analyzed by standardized and modern analytical methods.
from 15 days post-partum to 98 days post-partum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in fatty acid profile in mother's milk
Time Frame: from 15 days post-partum to 98 days post-partum
Fatty acid content in milk will be analyzed by standardized and modern analytical methods
from 15 days post-partum to 98 days post-partum
Assessment of dietary intake of macro and micronutrients by mother
Time Frame: From 15 days post-partum to 98 days post-delivery
Dietary intake of the mother will be assessed by a food frequency questionnaire (FFQ). Nutrient analysis of the FFQ will be done using a standardized nutrient database.
From 15 days post-partum to 98 days post-delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Deepti Khanna, Ph.D., Abbott Nutrition Research & Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AL21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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