Malnutrition Clinical Trial
— BeLiveOfficial title:
The Effect of Vitamin B12 Supplementation in Nepali Infants on Growth and Development
Verified date | July 2022 |
Source | Centre For International Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | December 28, 2024 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 11 Months |
Eligibility | Inclusion Criteria: - Age 6 to 11 months - Stunted - Availability of informed verbal consent - Plan to reside in the area for the next 12 months Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Nepal | Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan | Bhaktapur |
Lead Sponsor | Collaborator |
---|---|
Centre For International Health | NORCE Norwegian Research Centre AS, Tribhuvan University, Nepal |
Nepal,
Black 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. — View Citation
Black MM. Micronutrient deficiencies and cognitive functioning. J Nutr. 2003 Nov;133(11 Suppl 2):3927S-3931S. doi: 10.1093/jn/133.11.3927S. — View Citation
Strand 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Extended Followup: Neurodevelopment (IQ) | Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition. This is a test of general abilities ("IQ-test") Expected mean (SD): 100 (15), higher value indicate better cognitive functioning. Range approx. 40-140 | 3 years | |
Other | Surrogate Markers for Neurodevelopment | If funding allows, measure other markers related to neurodevelopment such as Brain Derived Neurotrophic Factor | 2 years | |
Primary | 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. | 12 months | |
Primary | Hemoglobin Concentration | Change in hemoglobin concentration from baseline to end study. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | Predictors for Neurodevelopment in Young Nepali Children | Using the collected data, identify morbidity, stimulation, nutrition, socioeconomic related predictors for neurodevelopment. | 12 months | |
Secondary | 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 | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | Leucocyte Telomere Length | Relative leucocyte telomere length at end of the study period. Estimated by real-time PCR analysis | 12 months | |
Secondary | 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. | 12 months |
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