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NCT00826657 Clinical Trial

Vitamin B12 Supplementation Study

Vitamin B12 Deficiency Clinical Trial

Official title:
Assessment of Functional Vitamin B12 Deficiency in Mexican Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00826657
Other study ID # 200412519-3
Secondary ID
Status Completed
Phase N/A
First received January 16, 2009
Last updated May 19, 2015
Start date October 2004
Est. completion date November 2006

Study information
Verified date May 2015
Source USDA, Western Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date November 2006
Est. primary completion date August 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 59 Years
Eligibility Inclusion Criteria:

- Women age 20-59, apparently healthy, no severe B12 deficiency

Exclusion Criteria:

- pregnancy, lactation, anemia and disease states

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin B12
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
• placebo
placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study

Locations
Country Name City State
Mexico Universidad Autonoma de Queretaro Queretaro

Sponsors (1)
Lead Sponsor Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations 0 and 3 mos No
Secondary DNA methylation change, and hematological response to B12 supplementation 0 and 3 mos No
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