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Vitamin B12 Supplementation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826657
First Posted: January 22, 2009
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
  Purpose
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.

Condition Intervention
Vitamin B12 Deficiency Dietary Supplement: Vitamin B12 Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Assessment of Functional Vitamin B12 Deficiency in Mexican Women

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations [ Time Frame: 0 and 3 mos ]

Secondary Outcome Measures:
  • DNA methylation change, and hematological response to B12 supplementation [ Time Frame: 0 and 3 mos ]

Enrollment: 180
Study Start Date: October 2004
Study Completion Date: November 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy, lactation, anemia and disease states
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826657


Locations
Mexico
Universidad Autonoma de Queretaro
Queretaro, Mexico
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00826657     History of Changes
Other Study ID Numbers: 200412519-3
First Submitted: January 16, 2009
First Posted: January 22, 2009
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by USDA, Western Human Nutrition Research Center:
B12 deficiency
methylmalonic acid
homocystein
vitamin B12 supplementation intervention

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Avitaminosis
Malnutrition
Nutrition Disorders
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics