Small for Gestational Age at DeliveryNCT01728766
Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age Bangladeshi Infants
An observational study of Small for Gestational Age at Delivery and Post-term Infant, Not Heavy-for-dates, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life. Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Small for Gestational Age at Delivery, Post-term Infant, Not Heavy-for-dates
- What is being tested?
- Small for gestational age at delivery and Post-term Infant, Not Heavy-for-dates
- How many people
- 76 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2006to Oct 2008
- 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 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants were 46 mothers and their term infants, 20 of whom were classified as appropriate for gestational age (AGA, birth weight >2800 g at ≥37 weeks of gestation) and 26 of whom were classified as small for gestational age (SGA, birth weight <2500 g at ≥37 weeks of gestation). Gestational age was assessed by ultrasonography at ~32 weeks of gestation. Only mothers who were planning to breast feed exclusively for at least four months were included in the study. Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study, as were infants with congenital abnormalities, chronic infections, or acute illnesses at the time of enrollment.
Who may be able to join
- AGA, birth weight >2800 g at ≥37 weeks of gestation
- SGA, birth weight <2500 g at ≥37 weeks of gestation
Who cannot join
- Other than the above birth weight
- Any congenital anomalies abnormalities, chronic infections as were infants with c, or acute illnesses at the time of enrollment
- Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study,
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh ( icddr,b),
Dhaka, 1212
About this study
Official title: Longitudinal Studies of Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age, Predominantly Breast Fed, Bangladeshi Infants
Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life.
Read the detailed description
The International Atomic Energy Agency (IAEA) has reviewed published literature to collect information for its Coordinated Research Project (CRP) on Zinc Nutrition During Early Life , and observed that there is limited information on: 1) the concentration of zinc in breast milk of mothers in lower income countries at different times post-partum; 2) the total amount of zinc transferred from mothers to infants at different ages in these settings, and 3) zinc transfer from mother to infant born with appropriate-for-gestational-age (AGA) and small-for-gestational-age (SGA). Therefore, IAEA has planned to assist local scientists to collect such information from selected countries. The International Zinc Nutrition Consultative Group (IZiNCG) has identified Bangladesh as a country with high risk of zinc deficiency (IZiNCG, 2004), where the rate of SGA infants is >30% - one of the highest in the world (de Onis, 1998). Thus, Bangladesh is an appropriate candidate country to participate in this CRP.
This study will enroll 50 healthy, full-term, newborn infants (>37 weeks gestational age by ultrasound) and their mothers if they plan to breast-feed exclusively for at least 4 months and also to continue breast feeding for at least 12 months. The infants will be examined, weighed and measured within 48 hours of birth, half of whom will be AGA (BW>2800g) and the other half SGA (BW<2500g). Infants with any acute or chronic illnesses, or congenital anomalies will not be eligible. Any mother with toxaemia, pregnancy-induced hypertension, multiple pregnancies, previously diagnosed as positive for HIV/hepatitis B infections, or habituated to smoking or alcohol consumption will also be excluded. The participants will be recruited from Nandipara, Dhaka, an urban community where the ICDDRB has ongoing clinical study facilities.
Each of the eligible mother-infant pairs will be studied in 3 separate rounds, at 4, 12 and 24 weeks post-partum. In each round, two-week studies of breast milk transfer from the mother to the infant will be carried out, using the deuterium "dose-to-the-mother" technique. In each round, the women will be requested to attend the Dhaka Hospital of ICDDR, B on day 0, for collection of baseline saliva samples from mother-infant pairs and administration of deuterium to the mothers. Study health workers will make home visits on days 1, 2, 3, 4, 13, and 14 and collect saliva samples from the infants and their mothers on days 1, 2, 13 and 14, of each round.
~2 ml of saliva will be collected for each sample from both the mother and the infant.
On days 0 and 4 of each round, 5-10 ml of manually-expressed breast milk will be collected for determining their zinc concentration. The total zinc transfer from mother to infant will be calculated as the product of the mean daily milk volume, as determined from the deuterium studies, and the mean milk zinc concentration on the days of milk collection.
On the first day of each of the rounds at 4, 12 and 24 week post-partum 2.0 ml of venous blood will be collected from both the mothers and infants for serum zinc assay.
Body weight, length and head circumference of infants, and body weight and height of mothers will be measured on day 0 at 4, 12 and 24 week post-partum.
Breast milk volume and zinc concentration, and total zinc transfer from mothers to infants will be the major outcome variables, which will be examined for conformance to the normal distribution and transformed if required. Means of the major outcome variables will be compared for AGA and SGA infants for each time points, using repeated measures ANOVA. Repeated measures analysis of covariance will be used to assess if these relationships change with age. Analyses will be done with SAS Release 9 and SPSS version 10.
- Being tested
- Small for gestational age at delivery, Post-term Infant, Not Heavy-for-dates
- Keywords
- Breast milk zinc transfer, Bangladeshi infants, appropriate-for-gestational-age, small-for-gestational-age, plasma zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small for gestational age at deliveryOther
Also called Small-for-Gestational Age (SGA)
Small for gestational age at delivery. gestational age at >37 weeks by and birth weight <2500 g
Post-term Infant, Not Heavy-for-datesOther
Also called Appropriate-for-gestational age (AGA)
Appropriate for gestational age at delivery. Gestational age at >37 weeks and birth weight >2800 g
| Study group | Role | What they receive |
|---|---|---|
| Infants under-6 months and their mothers | Small for gestational age at delivery. Post-term Infant, Not Heavy-for-dates. Receives: Other: Small for gestational age at delivery; Other: Post-term Infant, Not Heavy-for-dates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of zinc transferred through breast milk
During each round of study, a milk sample was collected during the visit to icddr,b on study day 1 and 5. On each occasion, the breast was cleansed with soap and water and rinsed with copious amounts of deionized water. The milk sample was then collected ~2-3 minutes after the feeding was initiated by momentarily removing the infant from the breast, so the study assistant could manually express 5-10 mL milk into a zinc-free beaker. The milk sample was then transferred to a plastic screw cap vial and transported to the laboratory, as described above for the saliva samples. The milk zinc concentration was measured by atomic absorption spectrometer (AAS, AA6501S, Shimadzu, Kyoto, Japan). The total zinc transfer from mother to infant was calculated as the product of the mean daily milk volume, as determined from the deuterium tracer studies, and the mean milk zinc concentration on the corresponding milk collection days.
Measured: at 4, 12 and 24 weeks after delivery of the infants
Secondary outcomes (1)
Plasma zinc content of both the mother and the infant
On the first morning of each round, 2 mL of venous blood was drawn from both the mother and infant for plasma zinc analyses, using stainless steel needles and certified trace element-free, evacuated collection tubes (Sarstedt LiH monovette, Sarstedt, Newton, NC, USA). The infant samples were drawn 90 minutes after the first morning feeding, but the mothers' samples were not timed in relation to meals. The plasma was separated within 60 minutes and stored at -20o C until analysis. The plasma samples were diluted (1:12) with distilled, deionized water, vortexed, and analyzed using the same AAS described above. The plasma samples were also compared with commercially available standard zinc nitrate solution (BDH, England), bi-level control serum (Cat # 66816; UTAK Laboratories Inc, Valencia, CA), and pooled serum to determine the accuracy and precision of the analyses.
Measured: at 4, 12 and 24 weeks after the delivery of the infants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational Age at DeliveryStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Dr M Munirul Islam, MBBS, PhD, Principal investigator, Associate Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728766
- Sponsor's protocol ID
- 2006-035
- Status last verified
- Nov 2012
- First submitted
- 4 Nov 2012
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Islam MM, Brown KH. Zinc transferred through breast milk does not differ between appropriate- and small-for-gestational-age, predominantly breast-fed Bangladeshi infants. J Nutr. 2014 May;144(5):771-6. doi: 10.3945/jn.113.189308. Epub 2014 Mar 5.
PubMed 24598881
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Studies of Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age, Predominantly Breast Fed, Bangladeshi Infants
- ClinicalTrials.gov ID
- NCT01728766
- Acronym / sponsor ID
- 2006-035
- Keywords
- Breast milk zinc transfer, Bangladeshi infants, appropriate-for-gestational-age, small-for-gestational-age, plasma zinc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Nov 2012 (estimated)
- 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.
Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life.
Detailed description
The International Atomic Energy Agency (IAEA) has reviewed published literature to collect information for its Coordinated Research Project (CRP) on Zinc Nutrition During Early Life , and observed that there is limited information on: 1) the concentration of zinc in breast milk of mothers in lower income countries at different times post-partum; 2) the total amount of zinc transferred from mothers to infants at different ages in these settings, and 3) zinc transfer from mother to infant born with appropriate-for-gestational-age (AGA) and small-for-gestational-age (SGA). Therefore, IAEA has planned to assist local scientists to collect such information from selected countries. The International Zinc Nutrition Consultative Group (IZiNCG) has identified Bangladesh as a country with high risk of zinc deficiency (IZiNCG, 2004), where the rate of SGA infants is >30% - one of the highest in the world (de Onis, 1998). Thus, Bangladesh is an appropriate candidate country to participate in this CRP.
This study will enroll 50 healthy, full-term, newborn infants (>37 weeks gestational age by ultrasound) and their mothers if they plan to breast-feed exclusively for at least 4 months and also to continue breast feeding for at least 12 months. The infants will be examined, weighed and measured within 48 hours of birth, half of whom will be AGA (BW>2800g) and the other half SGA (BW<2500g). Infants with any acute or chronic illnesses, or congenital anomalies will not be eligible. Any mother with toxaemia, pregnancy-induced hypertension, multiple pregnancies, previously diagnosed as positive for HIV/hepatitis B infections, or habituated to smoking or alcohol consumption will also be excluded. The participants will be recruited from Nandipara, Dhaka, an urban community where the ICDDRB has ongoing clinical study facilities.
Each of the eligible mother-infant pairs will be studied in 3 separate rounds, at 4, 12 and 24 weeks post-partum. In each round, two-week studies of breast milk transfer from the mother to the infant will be carried out, using the deuterium "dose-to-the-mother" technique. In each round, the women will be requested to attend the Dhaka Hospital of ICDDR, B on day 0, for collection of baseline saliva samples from mother-infant pairs and administration of deuterium to the mothers. Study health workers will make home visits on days 1, 2, 3, 4, 13, and 14 and collect saliva samples from the infants and their mothers on days 1, 2, 13 and 14, of each round.
~2 ml of saliva will be collected for each sample from both the mother and the infant.
On days 0 and 4 of each round, 5-10 ml of manually-expressed breast milk will be collected for determining their zinc concentration. The total zinc transfer from mother to infant will be calculated as the product of the mean daily milk volume, as determined from the deuterium studies, and the mean milk zinc concentration on the days of milk collection.
On the first day of each of the rounds at 4, 12 and 24 week post-partum 2.0 ml of venous blood will be collected from both the mothers and infants for serum zinc assay.
Body weight, length and head circumference of infants, and body weight and height of mothers will be measured on day 0 at 4, 12 and 24 week post-partum.
Breast milk volume and zinc concentration, and total zinc transfer from mothers to infants will be the major outcome variables, which will be examined for conformance to the normal distribution and transformed if required. Means of the major outcome variables will be compared for AGA and SGA infants for each time points, using repeated measures ANOVA. Repeated measures analysis of covariance will be used to assess if these relationships change with age. Analyses will be done with SAS Release 9 and SPSS version 10.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants under-6 months and their mothers | – | Other: Small for gestational age at delivery, Other: Post-term Infant, Not Heavy-for-datesSmall for gestational age at delivery. Post-term Infant, Not Heavy-for-dates. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants were 46 mothers and their term infants, 20 of whom were classified as appropriate for gestational age (AGA, birth weight >2800 g at ≥37 weeks of gestation) and 26 of whom were classified as small for gestational age (SGA, birth weight <2500 g at ≥37 weeks of gestation). Gestational age was assessed by ultrasonography at ~32 weeks of gestation. Only mothers who were planning to breast feed exclusively for at least four months were included in the study. Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study, as were infants with congenital abnormalities, chronic infections, or acute illnesses at the time of enrollment.
Key inclusion criteria (2 listed)
- AGA, birth weight >2800 g at ≥37 weeks of gestation
- SGA, birth weight <2500 g at ≥37 weeks of gestation
Key exclusion criteria (3 listed)
- Other than the above birth weight
- Any congenital anomalies abnormalities, chronic infections as were infants with c, or acute illnesses at the time of enrollment
- Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small for gestational age at deliveryAlso: Small-for-Gestational Age (SGA)Small for gestational age at delivery. gestational age at >37 weeks by and birth weight <2500 g | Other | Infants under-6 months and their mothers |
| Post-term Infant, Not Heavy-for-datesAlso: Appropriate-for-gestational age (AGA)Appropriate for gestational age at delivery. Gestational age at >37 weeks and birth weight >2800 g | Other | Infants under-6 months and their mothers |
Primary outcome
Amount of zinc transferred through breast milk
Time frame: at 4, 12 and 24 weeks after delivery of the infants
During each round of study, a milk sample was collected during the visit to icddr,b on study day 1 and 5. On each occasion, the breast was cleansed with soap and water and rinsed with copious amounts of deionized water. The milk sample was then collected ~2-3 minutes after the feeding was initiated by momentarily removing the infant from the breast, so the study assistant could manually express 5-10 mL milk into a zinc-free beaker. The milk sample was then transferred to a plastic screw cap vial and transported to the laboratory, as described above for the saliva samples. The milk zinc concentration was measured by atomic absorption spectrometer (AAS, AA6501S, Shimadzu, Kyoto, Japan). The total zinc transfer from mother to infant was calculated as the product of the mean daily milk volume, as determined from the deuterium tracer studies, and the mean milk zinc concentration on the corresponding milk collection days.
1 secondary outcome
Plasma zinc content of both the mother and the infant
Time frame: at 4, 12 and 24 weeks after the delivery of the infants
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 2 Jun 2017.
- Derived from this study: PubMed 24598881Islam MM, Brown KH. Zinc transferred through breast milk does not differ between appropriate- and small-for-gestational-age, predominantly breast-fed Bangladeshi infants. J Nutr. 2014 May;144(5):771-6. doi: 10.3945/jn.113.189308. Epub 2014 Mar 5.
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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.
Dr M Munirul Islam, MBBS, PhD principal investigator
Associate Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small for Gestational Age at Delivery and Post-term Infant, Not Heavy-for-dates, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 2 inclusion and 3 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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?
Amount of zinc transferred through breast milk (time frame: at 4, 12 and 24 weeks after delivery of the infants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01728766, which also lists 1 linked publication.
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 2 Jun 2017.