Vitamin B12 Supplementation Study
Not Applicable
Completed
- Conditions
- Vitamin B12 Deficiency
- Interventions
- Dietary Supplement: placeboDietary Supplement: Vitamin B12
- Registration Number
- NCT00826657
- Lead Sponsor
- USDA, Western Human Nutrition Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
Inclusion Criteria
- Women age 20-59, apparently healthy, no severe B12 deficiency
Exclusion Criteria
- pregnancy, lactation, anemia and disease states
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study. Vitamin B12 Vitamin B12 Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study
- Primary Outcome Measures
Name Time Method response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations 0 and 3 mos
- Secondary Outcome Measures
Name Time Method DNA methylation change, and hematological response to B12 supplementation 0 and 3 mos
Trial Locations
- Locations (1)
Universidad Autonoma de Queretaro
🇲🇽Queretaro, Mexico