Pregnancy RelatedPhase 2/3VitaPregNCT03071666
Vitamin B12 Supplementation During Pregnancy on Cognitive Development
A Phase 2/3 study testing cobalamin in people with Pregnancy Related and Vitamin B 12 Deficiency, run by Centre For International Health at 1 site in Nepal.
Trial summary
Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnancy Related, Vitamin B 12 Deficiency, Anemia
- What is being tested?
- cobalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteNepal
- Study dates
- 27 Mar 2017to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant mother in early pregnancy and not later than 15 weeks of pregnancy.
- Current resident and plan to reside in Bhaktapur district for at least the next 2 years.
- Age of mother between 18 and 40 years.
- Consent to participate in the study.
Who cannot join
- Taking or plan to take dietary or multivitamin supplements containing vitamin B12.
- Known case of chronic disease like asthma, tuberculosis, diabetes, hypertension, hypo or hyperthyroidism or others
- Known case of current high risk pregnancy
- Severe anemia (hemoglobin concentration <7 g/dL).
- Where the study doctor finds it necessary to treat the woman with vitamin B12 or vitamin B12 containing supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation of Vitamin B12 in Pregnancy and Postpartum on Growth and Cognitive Functioning in Early Childhood: A Randomized, Placebo Controlled Trial
Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes.
Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio.
Read more
Study participants and site: 800 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy.
Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth.
Comparator: Placebo, identical to the vitamin B12 supplements.
Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.
Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.
Read the detailed description
Cobalamin (Vitamin B12) deficiency is common in many low- and middle-income countries. This is not surprising as the main source of vitamin B12 is animal source foods, which are expensive and for cultural and religious reasons often not eaten at all. We have in several studies in women and children demonstrated that poor vitamin B12 status is common in South Asia. There is also compelling evidence that vitamin B12 deficiency occurs frequently in many other settings including pregnant women .
Case studies have demonstrated harmful effects of severe vitamin B12 deficiency on the developing infant brain.The consequences of mild or subclinical vitamin deficiency are less clear but it has been shown to be associated with decreased cognitive performance in both elderly and children.
Three randomized controlled trials (RCT) have measured the effect of vitamin B12 supplementation on neurodevelopment in children: In a Norwegian trial, an intramuscular injection of B12 substantially improved motor development in six weeks old infants after one month. Another intervention study in low birth weight children in Norway recently confirmed these findings. The infants in these studies had evidence of suboptimal vitamin B12 status, but none were severely deficient. We found a beneficial effect of vitamin B12 supplementation for six months on neurodevelopment in young North Indian children.
During pregnancy, vitamin B12 is concentrated in the fetus and stored in the liver. Infants born to vitamin B12-replete mothers have stores of vitamin B12 that are adequate to sustain them for the first several months postpartum. Consequently, vitamin B12 deficiency rarely occurs before the infant is about four months old if the mother has adequate vitamin B12 status during pregnancy. However, many infants of vitamin B12-deficient breastfeeding mothers are vulnerable to B12 deficiency from an early age.
In this project we will randomise Nepalese women to receive a supplement containing 50µg cobalamin or a placebo from early pregnancy until 6 months postpartum.
Hypothesis to be tested
Principal hypothesis: Daily administration of vitamin B12 to pregnant women from early pregnancy until 6 months postpartum will:
- Increase the scores of the Bayley Scales of Infant and Toddler Development, 3rd ed. (Bayley-III) by 0.25 SD points measured at 6 and 12 months of age.
- Increase length for age and weight for length by 0.2 z-scores at 12 months of age.
Other hypotheses to be tested (dependent on additional funding):
- Daily maternal administration of vitamin B12 from the start of the early pregnancy and for 6 months postpartum improves the hemoglobin concentration in the mother and infant.
- Daily maternal administration of vitamin B12 from early pregnancy and for 6 months postpartum improves plasma vitamin B12 concentration and reduces plasma total homocysteine and methylmalonic acid concentration in the mother and infant.
- Daily maternal administration of vitamin B12 from early pregnancy and for 6 months postpartum improves insulin sensitivity in the offspring.
- Conditions
- Pregnancy Related, Vitamin B 12 Deficiency, Anemia
- Being tested
- cobalamin, placebo
- Keywords
- Nepal, South Asia, Nutrition, Pregnancy, Neurodevelopment, Growth
- Medical subject headings
- Vitamin B 12 Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobalaminDietary supplement
Also called Vitamin B12
Vitamin supplment tablet containing 50µg cobalamin
placeboDietary supplement
A tablet identical to the vitamin supplement but containing no vitamin B12
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12 | Experimental | cobalamin, 50 µg per day throughout pregnancy and during the first 6 months postpartum. Receives: Dietary Supplement: cobalamin |
| Placebo | Placebo comparator | Identical taste and appearance with the Experimental arm. Contains no cobalamin Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length
Length measured in centimeters and expressed as z-scores
Measured: 12 months of age
Neurodevelopment
Cognitive composite score of the Bayley Scales of Infant and Toddler Development, 3rd ed. (Bayley-III)
Measured: measured 6 and 12 months of age
Secondary outcomes (14)
Child hemoglobin concentration
Hemoglobin measured by hemocue in full blood
Measured: measured 6 and 12 months of age
Child development ASQ
Total and subscale scores of the Ages and Stages Questionnaire - 3rd ed.
Measured: 12 first months of life
Child development Bayley
Subscale scores of the Bayley Scales of Infant and Toddler Development, 3rd ed. (Bayley-III)
Measured: measured 6 and 12 months of age
Heart rate variability
Heart rate variability or vagal tone
Measured: 12 first months of life
Sleep and activity
Sleep and activity measured by Actigraph (Actiwatch)
Measured: 12 first months of life
The Infant Motor Performance
Screening tool to assess motor development
Measured: 2 months after birth
Still births
Number of still births
Measured: Birth.
Maternal hemoglobin concentration
Hemoglobin measured by hemocue in full blood
Measured: at end of pregnancy and 6 and 12 months post party.
Number of complicated births
Number of births that were complicated
Measured: Birth.
Children born at small for gestational age
Number of children born at small for gestational age
Measured: Birth
Birth weight
weight in g
Measured: Birth
Low birth weight
Birthweight < 2,500 g
Measured: Birth
Very low birth weight
Birthweight < 2,000 g
Measured: Birth
High birth weight
Birthweight > 4,000 g
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start27 Mar 2017
- Primary completion28 Jun 2022
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University Teaching Hospital, Institute Of Medicine., NORCE Norwegian Research Centre AS, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Tor A Strand, MD/PhD, Principal investigator, University of BergenLaxman Shestha, MD, Principal investigator, Tribhuvan University, NepalRam K Chandyo, MD/PhD, Principal investigator, Kathmandu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071666
- Sponsor's protocol ID
- CISMAC-B12
- Other IDs
- Universal Trial Number
- Acronym
- VitaPreg
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2017
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared with other researchers upon request after completion of the study (data collection) and after publication of the main outcomes. And if the ethical review boards approve the use of the data for other purposes that what is described in the proposal.
Publications
Allen LH. Causes of vitamin B12 and folate deficiency. Food Nutr Bull. 2008 Jun;29(2 Suppl):S20-34; discussion S35-7. doi: 10.1177/15648265080292S105.
PubMed 18709879Samuel TM, Duggan C, Thomas T, Bosch R, Rajendran R, Virtanen SM, Srinivasan K, Kurpad AV. Vitamin B(12) intake and status in early pregnancy among urban South Indian women. Ann Nutr Metab. 2013;62(2):113-22. doi: 10.1159/000345589. Epub 2013 Jan 22.
PubMed 23344013Taneja S, Bhandari N, Strand TA, Sommerfelt H, Refsum H, Ueland PM, Schneede J, Bahl R, Bhan MK. Cobalamin and folate status in infants and young children in a low-to-middle income community in India. Am J Clin Nutr. 2007 Nov;86(5):1302-9. doi: 10.1093/ajcn/86.5.1302.
PubMed 17991639Ulak M, Chandyo RK, Adhikari RK, Sharma PR, Sommerfelt H, Refsum H, Strand TA. Cobalamin and folate status in 6 to 35 months old children presenting with acute diarrhea in Bhaktapur, Nepal. PLoS One. 2014 Mar 3;9(3):e90079. doi: 10.1371/journal.pone.0090079. eCollection 2014.
PubMed 24594935Dror DK, Allen LH. Effect of vitamin B12 deficiency on neurodevelopment in infants: current knowledge and possible mechanisms. Nutr Rev. 2008 May;66(5):250-5. doi: 10.1111/j.1753-4887.2008.00031.x.
PubMed 18454811Strand TA, Taneja S, Ueland PM, Refsum H, Bahl R, Schneede J, Sommerfelt H, Bhandari N. Cobalamin and folate status predicts mental development scores in North Indian children 12-18 mo of age. Am J Clin Nutr. 2013 Feb;97(2):310-7. doi: 10.3945/ajcn.111.032268. Epub 2013 Jan 2.
PubMed 23283502Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.
PubMed 24025626Kvestad I, Taneja S, Kumar T, Hysing M, Refsum H, Yajnik CS, Bhandari N, Strand TA; Folate and Vitamin B12 Study Group. Vitamin B12 and Folic Acid Improve Gross Motor and Problem-Solving Skills in Young North Indian Children: A Randomized Placebo-Controlled Trial. PLoS One. 2015 Jun 22;10(6):e0129915. doi: 10.1371/journal.pone.0129915. eCollection 2015.
PubMed 26098427Duggan C, Srinivasan K, Thomas T, Samuel T, Rajendran R, Muthayya S, Finkelstein JL, Lukose A, Fawzi W, Allen LH, Bosch RJ, Kurpad AV. Vitamin B-12 supplementation during pregnancy and early lactation increases maternal, breast milk, and infant measures of vitamin B-12 status. J Nutr. 2014 May;144(5):758-64. doi: 10.3945/jn.113.187278. Epub 2014 Mar 5.
PubMed 24598885Taneja S, Strand TA, Kumar T, Mahesh M, Mohan S, Manger MS, Refsum H, Yajnik CS, Bhandari N. Folic acid and vitamin B-12 supplementation and common infections in 6-30-mo-old children in India: a randomized placebo-controlled trial. Am J Clin Nutr. 2013 Sep;98(3):731-7. doi: 10.3945/ajcn.113.059592. Epub 2013 Jul 31.
PubMed 23902779Strand TA, Taneja S, Kumar T, Manger MS, Refsum H, Yajnik CS, Bhandari N. Vitamin B-12, folic acid, and growth in 6- to 30-month-old children: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):e918-26. doi: 10.1542/peds.2014-1848.
PubMed 25802345Kumar T, Taneja S, Yajnik CS, Bhandari N, Strand TA; Study Group. Prevalence and predictors of anemia in a population of North Indian children. Nutrition. 2014 May;30(5):531-7. doi: 10.1016/j.nut.2013.09.015. Epub 2013 Oct 15.
PubMed 24560137Yajnik CS, Deshpande SS, Jackson AA, Refsum H, Rao S, Fisher DJ, Bhat DS, Naik SS, Coyaji KJ, Joglekar CV, Joshi N, Lubree HG, Deshpande VU, Rege SS, Fall CH. Vitamin B12 and folate concentrations during pregnancy and insulin resistance in the offspring: the Pune Maternal Nutrition Study. Diabetologia. 2008 Jan;51(1):29-38. doi: 10.1007/s00125-007-0793-y. Epub 2007 Sep 13.
PubMed 17851649Strand TA, Averina M, Bakken KS, Basnet S, Bottcher Y, Huber S, Hysing M, Kvestad I, Luders T, McCann A, Pokhrel D, Ranjitkar S, Sharma AK, Shrestha M, Ulak M, Chandyo RK. Early-Life Exposures, Neurodevelopment, and Health Outcomes: Protocol for a Birth Cohort Study. JMIR Res Protoc. 2026 Feb 11;15:e78593. doi: 10.2196/78593.
PubMed 41493372Kvestad I, Ulak M, McCann A, Chandyo RK, Hysing M, Schwinger C, Ranjitkar S, Ueland PM, Basnet S, Strand TA. The Effect of Vitamin B-12 Supplementation During Pregnancy on Early Motor Performance: Secondary Analyses From a Double-Blinded Randomized Controlled Trial. J Nutr. 2026 Feb;156(2):101305. doi: 10.1016/j.tjnut.2025.101305. Epub 2025 Dec 27.
PubMed 41461260
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Vitamin B12 in Pregnancy and Postpartum on Growth and Cognitive Functioning in Early Childhood: A Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03071666
- Acronym / sponsor ID
- VitaPreg / CISMAC-B12
- Conditions
- Pregnancy Related, Vitamin B 12 Deficiency, Anemia
- Keywords
- Nepal, South Asia, Nutrition, Pregnancy, Neurodevelopment, Growth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Tribhuvan University Teaching Hospital, Institute Of Medicine., NORCE Norwegian Research Centre AS, Sykehuset Innlandet HF
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Mar 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.
Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes.
Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio.
Study participants and site: 800 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy.
Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth.
Comparator: Placebo, identical to the vitamin B12 supplements.
Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.
Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.
Detailed description
Cobalamin (Vitamin B12) deficiency is common in many low- and middle-income countries. This is not surprising as the main source of vitamin B12 is animal source foods, which are expensive and for cultural and religious reasons often not eaten at all. We have in several studies in women and children demonstrated that poor vitamin B12 status is common in South Asia. There is also compelling evidence that vitamin B12 deficiency occurs frequently in many other settings including pregnant women .
Case studies have demonstrated harmful effects of severe vitamin B12 deficiency on the developing infant brain.The consequences of mild or subclinical vitamin deficiency are less clear but it has been shown to be associated with decreased cognitive performance in both elderly and children.
Three randomized controlled trials (RCT) have measured the effect of vitamin B12 supplementation on neurodevelopment in children: In a Norwegian trial, an intramuscular injection of B12 substantially improved motor development in six weeks old infants after one month. Another intervention study in low birth weight children in Norway recently confirmed these findings. The infants in these studies had evidence of suboptimal vitamin B12 status, but none were severely deficient. We found a beneficial effect of vitamin B12 supplementation for six months on neurodevelopment in young North Indian children.
During pregnancy, vitamin B12 is concentrated in the fetus and stored in the liver. Infants born to vitamin B12-replete mothers have stores of vitamin B12 that are adequate to sustain them for the first several months postpartum. Consequently, vitamin B12 deficiency rarely occurs before the infant is about four months old if the mother has adequate vitamin B12 status during pregnancy. However, many infants of vitamin B12-deficient breastfeeding mothers are vulnerable to B12 deficiency from an early age.
In this project we will randomise Nepalese women to receive a supplement containing 50µg cobalamin or a placebo from early pregnancy until 6 months postpartum.
Hypothesis to be tested
Principal hypothesis: Daily administration of vitamin B12 to pregnant women from early pregnancy until 6 months postpartum will:
- Increase the scores of the Bayley Scales of Infant and Toddler Development, 3rd ed. (Bayley-III) by 0.25 SD points measured at 6 and 12 months of age.
- Increase length for age and weight for length by 0.2 z-scores at 12 months of age.
Other hypotheses to be tested (dependent on additional funding):
- Daily maternal administration of vitamin B12 from the start of the early pregnancy and for 6 months postpartum improves the hemoglobin concentration in the mother and infant.
- Daily maternal administration of vitamin B12 from early pregnancy and for 6 months postpartum improves plasma vitamin B12 concentration and reduces plasma total homocysteine and methylmalonic acid concentration in the mother and infant.
- Daily maternal administration of vitamin B12 from early pregnancy and for 6 months postpartum improves insulin sensitivity in the offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B12 | Experimental | Dietary Supplement: cobalamincobalamin, 50 µg per day throughout pregnancy and during the first 6 months postpartum. |
| Placebo | Placebo comparator | Dietary Supplement: placeboIdentical taste and appearance with the Experimental arm. Contains no cobalamin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant mother in early pregnancy and not later than 15 weeks of pregnancy.
- Current resident and plan to reside in Bhaktapur district for at least the next 2 years.
- Age of mother between 18 and 40 years.
- Consent to participate in the study.
Key exclusion criteria (5 listed)
- Taking or plan to take dietary or multivitamin supplements containing vitamin B12.
- Known case of chronic disease like asthma, tuberculosis, diabetes, hypertension, hypo or hyperthyroidism or others
- Known case of current high risk pregnancy
- Severe anemia (hemoglobin concentration <7 g/dL).
- Where the study doctor finds it necessary to treat the woman with vitamin B12 or vitamin B12 containing supplements
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 |
|---|---|---|
| cobalaminAlso: Vitamin B12Vitamin supplment tablet containing 50µg cobalamin | Dietary supplement | Vitamin B12 |
| placeboA tablet identical to the vitamin supplement but containing no vitamin B12 | Dietary supplement | Placebo |
Primary outcome
Length
Time frame: 12 months of age
Length measured in centimeters and expressed as z-scores
Neurodevelopment
Time frame: measured 6 and 12 months of age
Cognitive composite score of the Bayley Scales of Infant and Toddler Development, 3rd ed. (Bayley-III)
14 secondary outcomes
Child hemoglobin concentration
Time frame: measured 6 and 12 months of age
Child development ASQ
Time frame: 12 first months of life
Child development Bayley
Time frame: measured 6 and 12 months of age
Heart rate variability
Time frame: 12 first months of life
Sleep and activity
Time frame: 12 first months of life
The Infant Motor Performance
Time frame: 2 months after birth
Still births
Time frame: Birth.
Maternal hemoglobin concentration
Time frame: at end of pregnancy and 6 and 12 months post party.
Number of complicated births
Time frame: Birth.
Children born at small for gestational age
Time frame: Birth
Birth weight
Time frame: Birth
Low birth weight
Time frame: Birth
Very low birth weight
Time frame: Birth
High birth weight
Time frame: Birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 18709879Allen LH. Causes of vitamin B12 and folate deficiency. Food Nutr Bull. 2008 Jun;29(2 Suppl):S20-34; discussion S35-7. doi: 10.1177/15648265080292S105.
- Background: PubMed 23344013Samuel TM, Duggan C, Thomas T, Bosch R, Rajendran R, Virtanen SM, Srinivasan K, Kurpad AV. Vitamin B(12) intake and status in early pregnancy among urban South Indian women. Ann Nutr Metab. 2013;62(2):113-22. doi: 10.1159/000345589. Epub 2013 Jan 22.
- Background: PubMed 17991639Taneja S, Bhandari N, Strand TA, Sommerfelt H, Refsum H, Ueland PM, Schneede J, Bahl R, Bhan MK. Cobalamin and folate status in infants and young children in a low-to-middle income community in India. Am J Clin Nutr. 2007 Nov;86(5):1302-9. doi: 10.1093/ajcn/86.5.1302.
- Background: PubMed 24594935Ulak M, Chandyo RK, Adhikari RK, Sharma PR, Sommerfelt H, Refsum H, Strand TA. Cobalamin and folate status in 6 to 35 months old children presenting with acute diarrhea in Bhaktapur, Nepal. PLoS One. 2014 Mar 3;9(3):e90079. doi: 10.1371/journal.pone.0090079. eCollection 2014.
- Background: PubMed 18454811Dror DK, Allen LH. Effect of vitamin B12 deficiency on neurodevelopment in infants: current knowledge and possible mechanisms. Nutr Rev. 2008 May;66(5):250-5. doi: 10.1111/j.1753-4887.2008.00031.x.
- Background: PubMed 23283502Strand TA, Taneja S, Ueland PM, Refsum H, Bahl R, Schneede J, Sommerfelt H, Bhandari N. Cobalamin and folate status predicts mental development scores in North Indian children 12-18 mo of age. Am J Clin Nutr. 2013 Feb;97(2):310-7. doi: 10.3945/ajcn.111.032268. Epub 2013 Jan 2.
- Background: PubMed 24025626Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.
- Background: PubMed 26098427Kvestad I, Taneja S, Kumar T, Hysing M, Refsum H, Yajnik CS, Bhandari N, Strand TA; Folate and Vitamin B12 Study Group. Vitamin B12 and Folic Acid Improve Gross Motor and Problem-Solving Skills in Young North Indian Children: A Randomized Placebo-Controlled Trial. PLoS One. 2015 Jun 22;10(6):e0129915. doi: 10.1371/journal.pone.0129915. eCollection 2015.
- Background: PubMed 24598885Duggan C, Srinivasan K, Thomas T, Samuel T, Rajendran R, Muthayya S, Finkelstein JL, Lukose A, Fawzi W, Allen LH, Bosch RJ, Kurpad AV. Vitamin B-12 supplementation during pregnancy and early lactation increases maternal, breast milk, and infant measures of vitamin B-12 status. J Nutr. 2014 May;144(5):758-64. doi: 10.3945/jn.113.187278. Epub 2014 Mar 5.
- Background: PubMed 23902779Taneja S, Strand TA, Kumar T, Mahesh M, Mohan S, Manger MS, Refsum H, Yajnik CS, Bhandari N. Folic acid and vitamin B-12 supplementation and common infections in 6-30-mo-old children in India: a randomized placebo-controlled trial. Am J Clin Nutr. 2013 Sep;98(3):731-7. doi: 10.3945/ajcn.113.059592. Epub 2013 Jul 31.
- Background: PubMed 25802345Strand TA, Taneja S, Kumar T, Manger MS, Refsum H, Yajnik CS, Bhandari N. Vitamin B-12, folic acid, and growth in 6- to 30-month-old children: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):e918-26. doi: 10.1542/peds.2014-1848.
- Background: PubMed 24560137Kumar T, Taneja S, Yajnik CS, Bhandari N, Strand TA; Study Group. Prevalence and predictors of anemia in a population of North Indian children. Nutrition. 2014 May;30(5):531-7. doi: 10.1016/j.nut.2013.09.015. Epub 2013 Oct 15.
- Centre for Intervention Science in Maternal and Child healthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared with other researchers upon request after completion of the study (data collection) and after publication of the main outcomes. And if the ethical review boards approve the use of the data for other purposes that what is described in the proposal.
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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
Laxman Shestha, MD principal investigator
Tribhuvan University, Nepal
Ram K Chandyo, MD/PhD principal investigator
Kathmandu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cobalamin in people with Pregnancy Related and Vitamin B 12 Deficiency, 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Length (time frame: 12 months of age). The study lists 2 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 NCT03071666, which also lists 17 linked publications.
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 27 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.