Breast FeedingNCT03061929
Human Milk Composition in Indian Mothers
An observational study of Breast Feeding, run by Abbott Nutrition at 8 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- How many people
- 248 participants
- Where
- 8 sitesIndia
- Study dates
- 24 Mar 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Mother is at 33 to 42 weeks of pregnancy, is between 20 and 35 years of age and is contactable by telephone
- Mother is non smoker and non alcoholic.
- 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.
- Mother confirms her intention to breast feed for 4 months.
- Infant is a singleton with a gestational age of greater than 37 to 42 weeks and is able to feed from the mother normally.
- 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.
- Infant is judged to be in good health in the opinion of the investigator.
- 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.
Who cannot join
- 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.
- Mother has known gestational diabetes and/or a diagnosis of pre-eclampsia.
- 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.
- Mother had a breast surgery.
- Mother and or newborn infant has major illness that requires intensive care admission 24 hours.
- 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.
- Infant has major congenital anomaly in the PI's opinion
- Participation in another study that has not been approved as a concomitant study by AN.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
MS Ramaiah Medical College and Hospital
Bangalore, 560054
Sir Gangaram Hospital
Delhi, 110060
Institute of Child Health
Kolkata, 700017
Institute of Post Graduate Medical Education & Research and SSKM Hospital
Kolkata, 700020
King George Medical College & University
Lucknow, 226003
Cheluvumba Hospital
Mysore, 570021
King Edward Memorial Hospital
Pune, 411011
Sant Dnyadneshwar Medical Institute
Pune, 411030
About this 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.
Read the 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.
- Conditions
- Breast Feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in fat content of milk
Fat content will be analyzed by standardized and modern analytical methods.
Measured: from 15 days post-partum to 98 days post-partum
Secondary outcomes (2)
Change in fatty acid profile in mother's milk
Fatty acid content in milk will be analyzed by standardized and modern analytical methods
Measured: from 15 days post-partum to 98 days post-partum
Assessment of dietary intake of macro and micronutrients by mother
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.
Measured: From 15 days post-partum to 98 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start24 Mar 2017
- Primary completion30 May 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepti Khanna, Ph.D., Study chair, Abbott Nutrition Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061929
- Sponsor's protocol ID
- AL21
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Composition in Indian Mothers
- ClinicalTrials.gov ID
- NCT03061929
- Acronym / sponsor ID
- AL21
- Conditions
- Breast Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (8 listed)
- Mother is at 33 to 42 weeks of pregnancy, is between 20 and 35 years of age and is contactable by telephone
- Mother is non smoker and non alcoholic.
- 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.
- Mother confirms her intention to breast feed for 4 months.
- Infant is a singleton with a gestational age of greater than 37 to 42 weeks and is able to feed from the mother normally.
Key exclusion criteria (8 listed)
- 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.
- Mother has known gestational diabetes and/or a diagnosis of pre-eclampsia.
- 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.
- Mother had a breast surgery.
- Mother and or newborn infant has major illness that requires intensive care admission 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change in fatty acid profile in mother's milk
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
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Methyl Donor-Rich Diet in the Postpartum Period
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepti Khanna, Ph.D. study chair
Abbott Nutrition Research & Development
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Abbott Nutrition at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fat content of milk (time frame: from 15 days post-partum to 98 days post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.