DevelopmentPhase 2/3BeLiveNCT02272842
Vitamin B12, Neurodevelopment and Growth in Nepal
A Phase 2/3 study testing Vitamin B12 in people with Development and Vitamin Deficiency, run by Centre For International Health at 1 site in Nepal.
Trial summary
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Read more about this study
- Who is it for?
- Ages 6 to 11 months
- Conditions the study is for
- Development, Vitamin Deficiency, Malnutrition
- What is being tested?
- Vitamin B12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteNepal
- Study dates
- 20 Apr 2015to 28 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 11 months
- Stunted
- Availability of informed verbal consent
- Plan to reside in the area for the next 12 months
Who cannot join
- Severe systemic illness requiring hospitalization
- Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- Lack of consent
- Taking B vitamin supplements that include vitamin B12.
- Severe anemia (Hb < 7 g/dL). This would be a temporary exclusion and the children will be enrolled if they are successfully treated.
- Ongoing acute infection with fever or infection that requires medical treatment. This would be a temporary exclusion and the children will be enrolled after recovery.
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: The Effect of Vitamin B12 Supplementation in Nepali Infants on Growth and Development
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study.
Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time.
Read more
Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.
Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12.
Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood.
Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months
Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.
Read the detailed description
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. Vitamin B12 is crucial for normal cell division and differentiation and is necessary for the development and initial myelination of the central nervous system as well as for the maintenance of its normal function. Deficiency is also associated with impaired infant and child growth.
In a previous clinical trial, we demonstrated that vitamin B12 administration over a period of six months enhanced growth and neurodevelopment in young Indian children. The overall effect on growth was significant but small. We saw an effect on both ponderal (weight for age z scores) and linear (height for age z scores) growth. However, the overall effects were driven by the effects in the subgroups of children who were wasted, underweight or stunted at baseline, and no effect in the children who were not malnourished at baseline. This effect modification was significant for all three (stunting, wasting, and underweight) baseline variables. Similarly, the effect of the intervention on neurodevelopmental scores was also strongest in the subgroup of children that were stunted.
We have for the last 15 years undertaken studies on dietary intake and status in women and children in Bhaktapur, Nepal. In this site, vitamin B12 deficiency is very common. The objective of the proposed study is to measure to what extent administration of 2 RDA of vitamin B12 to stunted children from the last half of infancy and for 12 months affect neurodevelopment, growth and hemoglobin concentration.
Hypothesis: Daily supplementation of 2 RDA of vitamin B12 in young Nepali children for 12 months improves neurodevelopment, growth and hemoglobin concentration.
Study design: Individually randomized placebo controlled, double blind trial. Children will be identified in the community and stunted children will be randomized to daily receive a paste containing vitamin B12 or a placebo paste. The paste will be delivered by trained field workers every day and by the caregivers on Saturdays and public holidays.
Study participants and site: 600 stunted children aged 6 to 11 months in Bhaktapur municipality and surrounding areas.
Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months.
Comparator: Placebo, identical to the vitamin B12 supplements.
Data: Primary outcomes: (i) neurodevelopmental scores measured by Bayley Scales of Infant and Toddler Development 3rd edition and the Ages and Stages Questionnaire 3rd edition after 6 and 12 months of supplementation (ii) growth measured by change in height for age, weight for age and weight for height z-score from study start to end study and growth velocity z scores during the six first and six last months of supplementation (iii) hemoglobin concentration after 12 months of supplementation. Secondary: (i) cognitive development in children measured approximately 3 and 6 years after enrollment, (ii) linear and ponderal growth measured 2 and 3 years after enrollment, (iii) hemoglobin concentration measured 2 and 3 years after enrollment. All secondary outcomes require additional funding.
Relevance for programs and public health: Improved learning ability and growth in young malnourished children. If the supplementation is effective this will have consequences for dietary recommendation to malnourished children worldwide. In contrast to most other relevant nutritional interventions, vitamin B12 is inexpensive and our body has the ability to store vitamin B12, up to years. Thus, improving the status of this nutrient for a limited time period may have impact on learning and productivity beyond the time of administration and help to lift poor children out of the vicious cycle of poverty and malnutrition.
- Conditions
- Development, Vitamin Deficiency, Malnutrition
- Being tested
- Vitamin B12
- Keywords
- Nepal, Cobalamin, Neurodevelopment, Stunting, Growth
- Medical subject headings
- Avitaminosis, Malnutrition, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
Also called Cobalamin
Vitamin B12 in a multivitamin paste.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12 | Experimental | A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India) Receives: Dietary Supplement: Vitamin B12 |
| Placebo | Placebo comparator | A paste containing no vitamin administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India) Receives: Dietary Supplement: Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bayley Scales of Infant Development Version 3
Cognitive, Fine Motor, Gross Motor, Receptive language, and Expressive language scaled scores of the Bayley Scales of Infant Development version 3. This scale measures different aspects of neurodevelopment. The mean (SD) scores are usually 100 (15), and 95% of the population has scores between 70 and 130 (theoretical max/means 0/200). The higher scores, the better neurodevelopment; the scale is normalized on age.
Measured: 12 months
Hemoglobin Concentration
Change in hemoglobin concentration from baseline to end study.
Measured: 12 months
Secondary outcomes (8)
Growth Velocity Over the First Six Months of Supplementation
length and weight growth velocity z scores during supplementation z-scores, growth velocity. theoretical values -10 to 10 The higher the value, the faster the growth.
Measured: 12 months
Predictors for Neurodevelopment in Young Nepali Children
Using the collected data, identify morbidity, stimulation, nutrition, socioeconomic related predictors for neurodevelopment.
Measured: 12 months
Identify Subgroups of Children Who Benefit From Vitamin B12 Supplementation
Based on selected baseline variables we will identify subgroups who benefit from vitamin B12 supplementation
Measured: 12 months
The Effect of Vitamin B12 Supplementation on Markers of Vitamin B Status
We will draw a blood sample at study start and at end study to measure to what extent vitamin status is altered.
Measured: 12 months
Neurodevelopment Measured by Other Tools.
We will measure to what extent vitamin B12 supplementation improves neurodevelopment measured by other tools such as the Ages and Stages Questionnaire (version 3) and the NEPSY II test.
Measured: 12 months
Immediate Adverse Effects of the Intervention
We will investigate side effects such as pain, nausea, vomiting, regurgitation, allergic reactions and others after each dose of the intervention.
Measured: 12 months
Leucocyte Telomere Length
Relative leucocyte telomere length at end of the study period. Estimated by real-time PCR analysis
Measured: 12 months
Sleep Duration
Using actigraph and a structured questionaire on all children at baseline and at end of study measure the extent to which the intervention affects sleep.
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 Oct 2014 (estimated)
- Study start20 Apr 2015
- Primary completion28 Feb 2018
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DevelopmentStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University, Nepal, NORCE Norwegian Research Centre AS
- Responsible party
- Sponsor
- Investigators
- Prakash S Shrestha, MD, Principal investigator, Tribhuvan University, NepalTor A Strand, MD/PhD, Principal investigator, Innlandet Hospital Trust / University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272842
- Sponsor's protocol ID
- 808734
- Other IDs
- U1111-1161-5187
- Acronym
- BeLive
- Status last verified
- Jul 2022
- First submitted
- 21 Oct 2014
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data available on request. In order to meet ethical requirements for the use of confidential patient data, requests must be approved by the Nepal Health Research Council (NHRC) and the Regional Committee for Medical and Health Research Ethics in Norway. Requests for data should be sent to the authors, by contacting NHRC (http://nhrc.gov.np), or by contacting the Department of Global Health and Primary Care at the University of Bergen (post@igs.uib.no).
Publications
Taneja 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, 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 23283502Black MM. Effects of vitamin B12 and folate deficiency on brain development in children. Food Nutr Bull. 2008 Jun;29(2 Suppl):S126-31. doi: 10.1177/15648265080292S117.
PubMed 18709887Black MM. Micronutrient deficiencies and cognitive functioning. J Nutr. 2003 Nov;133(11 Suppl 2):3927S-3931S. doi: 10.1093/jn/133.11.3927S.
PubMed 14672291Strand TA, Chandyo RK, McCann A, Ranjitkar S, Ulak M, Kvestad I, Bakken KS, Ueland PM, Shrestha M, Shrestha L. The Effect of Daily Vitamin B-12 Supplementation on the Incidence of Common Childhood Infections in Nepal: Secondary Outcomes from a Double-Blind Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101534. doi: 10.1016/j.tjnut.2026.101534. Epub 2026 Apr 15.
PubMed 41997492Ulak M, Kvestad I, Chandyo RK, Schwinger C, Basnet S, Shrestha M, Ranjitkar S, Nguyen LV, Corona-Perez D, De Vivo I, Ueland PM, McCann A, Strand TA. The Effect of Vitamin B12 Supplementation on Leukocyte Telomere Length in Mildly Stunted Nepalese Children: A Secondary Outcome of a Randomized Controlled Trial. J Nutr. 2024 Aug;154(8):2543-2550. doi: 10.1016/j.tjnut.2023.10.015. Epub 2023 Oct 31.
PubMed 37918674Chandyo RK, Schwinger C, Kvestad I, Ulak M, Ranjitkar S, Shrestha M, Nguyen LV, Corona-Perez D, DeVivo I, Shrestha L, Strand TA. The association between household biomass fuel use and leukocyte telomere length among toddlers in Bhaktapur, Nepal. J Expo Sci Environ Epidemiol. 2023 May;33(3):448-454. doi: 10.1038/s41370-022-00474-1. Epub 2022 Sep 22.
PubMed 36138138Hysing M, Strand TA, Chandyo RK, Ulak M, Ranjitkar S, Schwinger C, Shrestha M, Kvestad I. The effect of vitamin B12-supplementation on actigraphy measured sleep pattern; a randomized control trial. Clin Nutr. 2022 Feb;41(2):307-312. doi: 10.1016/j.clnu.2021.11.040. Epub 2021 Dec 6.
PubMed 34999324Strand TA, Ulak M, Hysing M, Ranjitkar S, Kvestad I, Shrestha M, Ueland PM, McCann A, Shrestha PS, Shrestha LS, Chandyo RK. Effects of vitamin B12 supplementation on neurodevelopment and growth in Nepalese Infants: A randomized controlled trial. PLoS Med. 2020 Dec 1;17(12):e1003430. doi: 10.1371/journal.pmed.1003430. eCollection 2020 Dec.
PubMed 33259482Strand TA, Ulak M, Chandyo RK, Kvestad I, Hysing M, Shrestha M, Basnet S, Ranjitkar S, Shrestha L, Shrestha PS. The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial. Trials. 2017 Apr 21;18(1):187. doi: 10.1186/s13063-017-1937-0.
PubMed 28431557
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin B12 Supplementation in Nepali Infants on Growth and Development
- ClinicalTrials.gov ID
- NCT02272842
- Acronym / sponsor ID
- BeLive / 808734
- Conditions
- Development, Vitamin Deficiency, Malnutrition
- Keywords
- Nepal, Cobalamin, Neurodevelopment, Stunting, Growth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Tribhuvan University, Nepal, NORCE Norwegian Research Centre AS
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study.
Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time.
Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.
Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12.
Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood.
Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months
Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.
Detailed description
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. Vitamin B12 is crucial for normal cell division and differentiation and is necessary for the development and initial myelination of the central nervous system as well as for the maintenance of its normal function. Deficiency is also associated with impaired infant and child growth.
In a previous clinical trial, we demonstrated that vitamin B12 administration over a period of six months enhanced growth and neurodevelopment in young Indian children. The overall effect on growth was significant but small. We saw an effect on both ponderal (weight for age z scores) and linear (height for age z scores) growth. However, the overall effects were driven by the effects in the subgroups of children who were wasted, underweight or stunted at baseline, and no effect in the children who were not malnourished at baseline. This effect modification was significant for all three (stunting, wasting, and underweight) baseline variables. Similarly, the effect of the intervention on neurodevelopmental scores was also strongest in the subgroup of children that were stunted.
We have for the last 15 years undertaken studies on dietary intake and status in women and children in Bhaktapur, Nepal. In this site, vitamin B12 deficiency is very common. The objective of the proposed study is to measure to what extent administration of 2 RDA of vitamin B12 to stunted children from the last half of infancy and for 12 months affect neurodevelopment, growth and hemoglobin concentration.
Hypothesis: Daily supplementation of 2 RDA of vitamin B12 in young Nepali children for 12 months improves neurodevelopment, growth and hemoglobin concentration.
Study design: Individually randomized placebo controlled, double blind trial. Children will be identified in the community and stunted children will be randomized to daily receive a paste containing vitamin B12 or a placebo paste. The paste will be delivered by trained field workers every day and by the caregivers on Saturdays and public holidays.
Study participants and site: 600 stunted children aged 6 to 11 months in Bhaktapur municipality and surrounding areas.
Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months.
Comparator: Placebo, identical to the vitamin B12 supplements.
Data: Primary outcomes: (i) neurodevelopmental scores measured by Bayley Scales of Infant and Toddler Development 3rd edition and the Ages and Stages Questionnaire 3rd edition after 6 and 12 months of supplementation (ii) growth measured by change in height for age, weight for age and weight for height z-score from study start to end study and growth velocity z scores during the six first and six last months of supplementation (iii) hemoglobin concentration after 12 months of supplementation. Secondary: (i) cognitive development in children measured approximately 3 and 6 years after enrollment, (ii) linear and ponderal growth measured 2 and 3 years after enrollment, (iii) hemoglobin concentration measured 2 and 3 years after enrollment. All secondary outcomes require additional funding.
Relevance for programs and public health: Improved learning ability and growth in young malnourished children. If the supplementation is effective this will have consequences for dietary recommendation to malnourished children worldwide. In contrast to most other relevant nutritional interventions, vitamin B12 is inexpensive and our body has the ability to store vitamin B12, up to years. Thus, improving the status of this nutrient for a limited time period may have impact on learning and productivity beyond the time of administration and help to lift poor children out of the vicious cycle of poverty and malnutrition.
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: Vitamin B12A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India) |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin B12A paste containing no vitamin administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India) |
Who may qualify
- Ages
- 6 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 6 to 11 months
- Stunted
- Availability of informed verbal consent
- Plan to reside in the area for the next 12 months
Key exclusion criteria (6 listed)
- Severe systemic illness requiring hospitalization
- Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- Lack of consent
- Taking B vitamin supplements that include vitamin B12.
- Severe anemia (Hb < 7 g/dL). This would be a temporary exclusion and the children will be enrolled if they are successfully treated.
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 B12Also: CobalaminVitamin B12 in a multivitamin paste. | Dietary supplement | Placebo, Vitamin B12 |
Primary outcome
The Bayley Scales of Infant Development Version 3
Time frame: 12 months
Cognitive, Fine Motor, Gross Motor, Receptive language, and Expressive language scaled scores of the Bayley Scales of Infant Development version 3. This scale measures different aspects of neurodevelopment. The mean (SD) scores are usually 100 (15), and 95% of the population has scores between 70 and 130 (theoretical max/means 0/200). The higher scores, the better neurodevelopment; the scale is normalized on age.
Hemoglobin Concentration
Time frame: 12 months
Change in hemoglobin concentration from baseline to end study.
8 secondary outcomes
Growth Velocity Over the First Six Months of Supplementation
Time frame: 12 months
Predictors for Neurodevelopment in Young Nepali Children
Time frame: 12 months
Identify Subgroups of Children Who Benefit From Vitamin B12 Supplementation
Time frame: 12 months
The Effect of Vitamin B12 Supplementation on Markers of Vitamin B Status
Time frame: 12 months
Neurodevelopment Measured by Other Tools.
Time frame: 12 months
Immediate Adverse Effects of the Intervention
Time frame: 12 months
Leucocyte Telomere Length
Time frame: 12 months
Sleep Duration
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 18709887Black MM. Effects of vitamin B12 and folate deficiency on brain development in children. Food Nutr Bull. 2008 Jun;29(2 Suppl):S126-31. doi: 10.1177/15648265080292S117.
- Background: PubMed 14672291Black MM. Micronutrient deficiencies and cognitive functioning. J Nutr. 2003 Nov;133(11 Suppl 2):3927S-3931S. doi: 10.1093/jn/133.11.3927S.
- Derived from this study: PubMed 41997492Strand TA, Chandyo RK, McCann A, Ranjitkar S, Ulak M, Kvestad I, Bakken KS, Ueland PM, Shrestha M, Shrestha L. The Effect of Daily Vitamin B-12 Supplementation on the Incidence of Common Childhood Infections in Nepal: Secondary Outcomes from a Double-Blind Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101534. doi: 10.1016/j.tjnut.2026.101534. Epub 2026 Apr 15.
- Derived from this study: PubMed 37918674Ulak M, Kvestad I, Chandyo RK, Schwinger C, Basnet S, Shrestha M, Ranjitkar S, Nguyen LV, Corona-Perez D, De Vivo I, Ueland PM, McCann A, Strand TA. The Effect of Vitamin B12 Supplementation on Leukocyte Telomere Length in Mildly Stunted Nepalese Children: A Secondary Outcome of a Randomized Controlled Trial. J Nutr. 2024 Aug;154(8):2543-2550. doi: 10.1016/j.tjnut.2023.10.015. Epub 2023 Oct 31.
- Derived from this study: PubMed 36138138Chandyo RK, Schwinger C, Kvestad I, Ulak M, Ranjitkar S, Shrestha M, Nguyen LV, Corona-Perez D, DeVivo I, Shrestha L, Strand TA. The association between household biomass fuel use and leukocyte telomere length among toddlers in Bhaktapur, Nepal. J Expo Sci Environ Epidemiol. 2023 May;33(3):448-454. doi: 10.1038/s41370-022-00474-1. Epub 2022 Sep 22.
- Derived from this study: PubMed 34999324Hysing M, Strand TA, Chandyo RK, Ulak M, Ranjitkar S, Schwinger C, Shrestha M, Kvestad I. The effect of vitamin B12-supplementation on actigraphy measured sleep pattern; a randomized control trial. Clin Nutr. 2022 Feb;41(2):307-312. doi: 10.1016/j.clnu.2021.11.040. Epub 2021 Dec 6.
- Derived from this study: PubMed 33259482Strand TA, Ulak M, Hysing M, Ranjitkar S, Kvestad I, Shrestha M, Ueland PM, McCann A, Shrestha PS, Shrestha LS, Chandyo RK. Effects of vitamin B12 supplementation on neurodevelopment and growth in Nepalese Infants: A randomized controlled trial. PLoS Med. 2020 Dec 1;17(12):e1003430. doi: 10.1371/journal.pmed.1003430. eCollection 2020 Dec.
- Derived from this study: PubMed 28431557Strand TA, Ulak M, Chandyo RK, Kvestad I, Hysing M, Shrestha M, Basnet S, Ranjitkar S, Shrestha L, Shrestha PS. The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial. Trials. 2017 Apr 21;18(1):187. doi: 10.1186/s13063-017-1937-0.
- Link to the founding source.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data available on request. In order to meet ethical requirements for the use of confidential patient data, requests must be approved by the Nepal Health Research Council (NHRC) and the Regional Committee for Medical and Health Research Ethics in Norway. Requests for data should be sent to the authors, by contacting NHRC (http://nhrc.gov.np), or by contacting the Department of Global Health and Primary Care at the University of Bergen (post@igs.uib.no).
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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.
Prakash S Shrestha, MD principal investigator
Tribhuvan University, Nepal
Tor A Strand, MD/PhD principal investigator
Innlandet Hospital Trust / University of Bergen
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 Vitamin B12 in people with Development and Vitamin 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 6 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: status not confirmed, as of the sponsor's last update on 18 Sep 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 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?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Bayley Scales of Infant Development Version 3 (time frame: 12 months). 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 NCT02272842, which also lists 10 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 18 Sep 2023.