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Vitamin B12 Supplementation Study

NCT00826657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-05-21

No results posted yet for this study

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.

Conditions

  • Vitamin B12 Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study

DIETARY_SUPPLEMENT

placebo

placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study

Sponsors & Collaborators

  • USDA, Western Human Nutrition Research Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-08-31
Completion
2006-11-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826657 on ClinicalTrials.gov