Vitamin B12 Deficiency
Conditions
Keywords
B12 deficiency, methylmalonic acid, homocystein, vitamin B12 supplementation intervention
Brief summary
We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity. However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin. This information will help decide weather supplementation with vitamin B12 is necessary in such populations for public health reasons.
Interventions
DIETARY_SUPPLEMENTVitamin B12
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
DIETARY_SUPPLEMENTplacebo
placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
Sponsors
USDA, Western Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Women age 20-59, apparently healthy, no severe B12 deficiency
Exclusion criteria
* pregnancy, lactation, anemia and disease states
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations | 0 and 3 mos |
Secondary
| Measure | Time frame |
|---|---|
| DNA methylation change, and hematological response to B12 supplementation | 0 and 3 mos |
Countries
Mexico
Outcome results
None listed