Vitamin B12 Supplementation Study

NCT ID: NCT00826657

Last Updated: 2015-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Vitamin B12 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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placebo

Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin B12

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

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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sugar pill

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy, lactation, anemia and disease states
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Autonoma de Queretaro

Querétaro, , Mexico

Site Status

Countries

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Mexico

References

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Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castaneda H, Rosado JL, Keyes WR, Newman JW, Miller JW, Allen LH. Vitamin B-12 supplementation of rural Mexican women changes biochemical vitamin B-12 status indicators but does not affect hematology or a bone turnover marker. J Nutr. 2012 Oct;142(10):1881-7. doi: 10.3945/jn.112.165712. Epub 2012 Aug 22.

Reference Type DERIVED
PMID: 22915298 (View on PubMed)

Other Identifiers

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200412519-3

Identifier Type: -

Identifier Source: org_study_id

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