Early PregnancyNCT03258385
Vitamin B12 Supplementation to Improve B12 Status and Child Development
A study testing Vitamin B12 fortified UHT milk and Plain UHT milk in people with Early Pregnancy, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy
- What is being tested?
- Vitamin B12 fortified UHT milk and Plain UHT milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2017to 30 Oct 2021
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. 18 - 35 y old 2. 11-14 wk pregnant (based on last menstrual period) 3. Willing to stay in Dhaka during pregnancy and remain in the area for the 12 mo following recruitment 4. Willing to be admitted in the clinic for delivery 5. Intends to exclusively or predominantly breastfeed infant until 6 mo of age
- -
Who cannot join
- 1. Women with severe anemia; Hb concentration <70 g/L 2. History or presence of systemic disease such as Diabetes mellitus, Hypertension 3. History of previous complicated pregnancies, pre-term delivery, or abortion 4. Current use of supplements containing vitamin B12 5. Children with acute illness or features suggestive of any chronic disease such as tuberculosis, any congenital anomalies such as cleft lip or palate.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin B12 Fortified Milk Supplementation During Pregnancy and 6 Month Postpartum to Improve B12 Status and Child Development
Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.
Read the detailed description
The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development. Pregnant women (n=148) will be randomized to receive B12-fortified milk (100 μg/day) or milk without fortification. The daily supplementation beginning at the baseline visit (GW 11-14) will continue until 6 mo-postpartum. Biomarkers of B12 status will be measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo). Infant development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler Development. Immune responses will be measured in infant at 3 and 6-mo. Data on socioeconomic status, dietary diversity, and anthropometric indices will be recorded at baseline. Additional tests in mothers include screening for H. pylori and plasma gastrin.
- Conditions
- Early Pregnancy
- Being tested
- Vitamin B12 fortified UHT milk, Plain UHT milk
- Keywords
- Vitamin B12, Fortified milk, Immunity, Child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 fortified UHT milkDietary supplement
Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12
Plain UHT milkDietary supplement
Daily intake of 200 mL of plain UHT milk
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12-fortified UHT milk | Active comparator | Supplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily Receives: Dietary Supplement: Vitamin B12 fortified UHT milk |
| Plain UHT milk | Placebo comparator | Placebo group (N=74) that will receive plain UHT milk daily Receives: Dietary Supplement: Plain UHT milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentrations of biomarkers of vitamin B12 in mother-child pairs
The investigators will determine the change in concentrations of biomarkers of B12 ( based on measurement of B12, MMA, tHcy, holoTC, cB12, folate in plasma; B12 in breast milk)
Measured: Baseline and 6 months postpartum
Vaccine specific immunity in infants
The investigators will determine the concentrations of vaccine specific IgA and IgG in plasma
Measured: 6 months
Cognitive, Language and Motor Composite Score
The outcomes are measured by Bayley-III test
Measured: 12 months
Nuroinflammatory cytokines
The investigators will determine the change in concentrations of EGF and TNF-α in plasma
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
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 Early PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 155 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, Nestlé Foundation
- Responsible party
- Sponsor
- Investigators
- Towfida J Siddiqua, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258385
- Sponsor's protocol ID
- PR-16003
- Status last verified
- Apr 2021
- First submitted
- 13 Aug 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Finkelstein JL, Fothergill A, Venkatramanan S, Layden AJ, Williams JL, Crider KS, Qi YP. Vitamin B12 supplementation during pregnancy for maternal and child health outcomes. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD013823. doi: 10.1002/14651858.CD013823.pub2.
PubMed 38189492
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin B12 Fortified Milk Supplementation During Pregnancy and 6 Month Postpartum to Improve B12 Status and Child Development
- ClinicalTrials.gov ID
- NCT03258385
- Acronym / sponsor ID
- PR-16003
- Conditions
- Early Pregnancy
- Keywords
- Vitamin B12, Fortified milk, Immunity, Child development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of California, Davis, Nestlé Foundation
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 23 Aug 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.
Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.
Detailed description
The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development. Pregnant women (n=148) will be randomized to receive B12-fortified milk (100 μg/day) or milk without fortification. The daily supplementation beginning at the baseline visit (GW 11-14) will continue until 6 mo-postpartum. Biomarkers of B12 status will be measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo). Infant development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler Development. Immune responses will be measured in infant at 3 and 6-mo. Data on socioeconomic status, dietary diversity, and anthropometric indices will be recorded at baseline. Additional tests in mothers include screening for H. pylori and plasma gastrin.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B12-fortified UHT milk | Active comparator | Dietary Supplement: Vitamin B12 fortified UHT milkSupplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily |
| Plain UHT milk | Placebo comparator | Dietary Supplement: Plain UHT milkPlacebo group (N=74) that will receive plain UHT milk daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. 18 - 35 y old 2. 11-14 wk pregnant (based on last menstrual period) 3. Willing to stay in Dhaka during pregnancy and remain in the area for the 12 mo following recruitment 4. Willing to be admitted in the clinic for delivery 5. Intends to exclusively or predominantly breastfeed infant until 6 mo of age
- -
Key exclusion criteria (2 listed)
- 1. Women with severe anemia; Hb concentration <70 g/L 2. History or presence of systemic disease such as Diabetes mellitus, Hypertension 3. History of previous complicated pregnancies, pre-term delivery, or abortion 4. Current use of supplements containing vitamin B12 5. Children with acute illness or features suggestive of any chronic disease such as tuberculosis, any congenital anomalies such as cleft lip or palate.
- -
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 |
|---|---|---|
| Vitamin B12 fortified UHT milkDaily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12 | Dietary supplement | Vitamin B12-fortified UHT milk |
| Plain UHT milkDaily intake of 200 mL of plain UHT milk | Dietary supplement | Plain UHT milk |
Primary outcome
Change in concentrations of biomarkers of vitamin B12 in mother-child pairs
Time frame: Baseline and 6 months postpartum
The investigators will determine the change in concentrations of biomarkers of B12 ( based on measurement of B12, MMA, tHcy, holoTC, cB12, folate in plasma; B12 in breast milk)
Vaccine specific immunity in infants
Time frame: 6 months
The investigators will determine the concentrations of vaccine specific IgA and IgG in plasma
Cognitive, Language and Motor Composite Score
Time frame: 12 months
The outcomes are measured by Bayley-III test
Nuroinflammatory cytokines
Time frame: 12 months
The investigators will determine the change in concentrations of EGF and TNF-α in plasma
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 Jan 2023.
- Derived from this study: PubMed 38189492Finkelstein JL, Fothergill A, Venkatramanan S, Layden AJ, Williams JL, Crider KS, Qi YP. Vitamin B12 supplementation during pregnancy for maternal and child health outcomes. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD013823. doi: 10.1002/14651858.CD013823.pub2.
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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.
Towfida J Siddiqua, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 fortified UHT milk and Plain UHT milk in people with Early Pregnancy, 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 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 Jan 2023. 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. Some participants in this study may receive a placebo. 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 concentrations of biomarkers of vitamin B12 in mother-child pairs (time frame: Baseline and 6 months postpartum). The study lists 4 primary outcomes in all. 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 NCT03258385, 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 18 Jan 2023.