Malnutrition, InfantNCT03285399
Bhaktapur Maternal and Child Micronutrient Study
An observational study of Malnutrition, Infant and Malnutrition; Anemia, run by Centre For International Health at 1 site in Nepal.
Trial summary
Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was… Read more about this study
- Who is it for?
- Ages 2 to 11 months
- Conditions the study is for
- Malnutrition, Infant, Malnutrition; Anemia
- How many people
- 1,000 participants
- Where
- 1 siteNepal
- Study dates
- 12 Jan 2008to 28 Feb 2014
- 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 2 to 11 months
- All sexes
- No healthy volunteers
- Child
Study population: A cross-sectional survey was carried out and 500 healthy lactating women (17-44 years old) were randomly selected from Bhaktapur municipality, Nepal. Bhaktapur is an urban area located 15 km east of the capital Kathmandu and was chosen because of the diversity of this population spanning all socio-economic strata, providing a unique opportunity to explore dietary variation.
Who may be able to join
- availability of consent
- no ongoing illness
- resides in the selected cluster
- that household information could be obtained
- that the mother was lactating
Who cannot join
- refused blood sampling
- chronic illness
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
Bhaktapur, P.O.Box 40
About this study
Official title: Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal
Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.
Read the detailed description
Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. The women attended a hospital for physical examination, dietary interview, and blood sampling. Blood samples were also collected from their infants who also went through a detailed clinical examination
The blood samples from mothers and infant pairs were collected approximately one week apart. The blood was spun down, plasma separated and transferred into storage vials immediately. Plasma and blood pellets were stored in cryovials at -70 until analysis.
All women were also requested to provide one breast milk and one urine sample.
Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis.
Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A, vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.
The breast milk will be analyzed for iodine, fatty acids, and several B vitamins
The urine was analyzed for iodine.
In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food security, and neurodevelopment.
- Conditions
- Malnutrition, Infant, Malnutrition; Anemia
- Keywords
- Nepal, Breastfeeding, Micronutrients, Women, Infants
- Medical subject headings
- Infant Nutrition Disorders, Malnutrition, Anemia, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of micronutrient deficiency
The status and prevalence of deficiencies of several micronutrients has been estimated
Measured: 1 year
Predictors for micronutrient status
We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.
Measured: 1 year
Prevalence of anaemia in mothers and children
Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.
Measured: 1 year
Secondary outcomes (4)
Neurodevelopment at 5 years
Neurodevelopment is measured when the children are 5 using the Ages and Stages questionnaire and the NEPSY II tests. These measures will be related to micronutrient status, inflammation and stress markers.
Measured: 5 years
Growth during infancy and at 5 years of age
Growth (length and weight) is measured when the children are 5 years and will be related to nutritional status.
Measured: 5 years
Markers of stress and inflammation.
Maternal and infants markers of inflammation (CRP, neopterine, kynurenic acid, kynurenine, tryphtophane, etc) and stress (leucocyte telomere length) will be measured and related to micronutrient status.
Measured: 1 year
Breastmilk b-vitamin concentration
The concentration of several b-vitamins will be estimated in the breast milk and related to dietary intake and maternal and child status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start12 Jan 2008
- Primary completion28 Feb 2010
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, InfantStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Harvard School of Public Health (HSPH), Oslo and Akershus University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Tor A Strand, MD/PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285399
- Sponsor's protocol ID
- 172226
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal
- ClinicalTrials.gov ID
- NCT03285399
- Acronym / sponsor ID
- 172226
- Conditions
- Malnutrition, Infant, Malnutrition; Anemia
- Keywords
- Nepal, Breastfeeding, Micronutrients, Women, Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Tribhuvan University, Nepal, Harvard School of Public Health (HSPH), Oslo and Akershus University of Applied Sciences
- Study start
- 12 Jan 2008 (actual)
- Primary completion
- 28 Feb 2010 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 18 Sep 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.
Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.
Detailed description
Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. The women attended a hospital for physical examination, dietary interview, and blood sampling. Blood samples were also collected from their infants who also went through a detailed clinical examination
The blood samples from mothers and infant pairs were collected approximately one week apart. The blood was spun down, plasma separated and transferred into storage vials immediately. Plasma and blood pellets were stored in cryovials at -70 until analysis.
All women were also requested to provide one breast milk and one urine sample.
Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis.
Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A, vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.
The breast milk will be analyzed for iodine, fatty acids, and several B vitamins
The urine was analyzed for iodine.
In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food security, and neurodevelopment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A cross-sectional survey was carried out and 500 healthy lactating women (17-44 years old) were randomly selected from Bhaktapur municipality, Nepal. Bhaktapur is an urban area located 15 km east of the capital Kathmandu and was chosen because of the diversity of this population spanning all socio-economic strata, providing a unique opportunity to explore dietary variation.
Key inclusion criteria (5 listed)
- availability of consent
- no ongoing illness
- resides in the selected cluster
- that household information could be obtained
- that the mother was lactating
Key exclusion criteria (2 listed)
- refused blood sampling
- chronic illness
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
Prevalence of micronutrient deficiency
Time frame: 1 year
The status and prevalence of deficiencies of several micronutrients has been estimated
Predictors for micronutrient status
Time frame: 1 year
We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.
Prevalence of anaemia in mothers and children
Time frame: 1 year
Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.
4 secondary outcomes
Neurodevelopment at 5 years
Time frame: 5 years
Growth during infancy and at 5 years of age
Time frame: 5 years
Markers of stress and inflammation.
Time frame: 1 year
Breastmilk b-vitamin concentration
Time frame: 1 year
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 18 Sep 2017.
- Individual participant dataSharing planned: Undecided. Data can be requested by contacting the principal investigator (Tor Strand) or one of the other investigators.
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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.
Tor A Strand, MD/PhD principal investigator
University of Bergen
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 Malnutrition, Infant and Malnutrition; Anemia, run by Centre For International Health at 1 site in Nepal.
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 5 inclusion and 2 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 18 Sep 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 Nepal. 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?
Prevalence of micronutrient deficiency (time frame: 1 year). The study lists 3 primary outcomes in all. 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 18 Sep 2017.