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Vitamin B12 Supplementation Study

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ClinicalTrials.gov Identifier: NCT00826657
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin B12 Deficiency Dietary Supplement: Vitamin B12 Dietary Supplement: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arms and Interventions
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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 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


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

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

Eligibility Criteria
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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
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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
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Mexico
Universidad Autonoma de Queretaro
Queretaro, Mexico
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00826657    
Other Study ID Numbers: 200412519-3
First Posted: January 22, 2009    Key Record Dates
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:
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Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin B 12
 Hydroxocobalamin
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Hematinics