Vitamin B12 Supplementation Study

May 19, 2015 updated by: USDA, Western Human Nutrition Research Center

Assessment of Functional Vitamin B12 Deficiency in Mexican Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Queretaro, Mexico
        • Universidad Autónoma de Querétaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy, lactation, anemia and disease states

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end 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
Other Names:
  • sugar pill
ACTIVE_COMPARATOR: 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
Dietary supplement: Vitamin B12
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
Time Frame: 0 and 3 mos
0 and 3 mos

Secondary Outcome Measures

Outcome Measure
Time Frame
DNA methylation change, and hematological response to B12 supplementation
Time Frame: 0 and 3 mos
0 and 3 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA, Western Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200412519-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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