Back to resultsVitamin B12 Supplementation Study
Primary Purpose
Vitamin B12 Deficiency
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin B12
placebo
Sponsored by
About this trial
This is an interventional health services research trial for Vitamin B12 Deficiency focused on measuring B12 deficiency, methylmalonic acid, homocystein, vitamin B12 supplementation intervention
Eligibility Criteria
Inclusion Criteria:
- Women age 20-59, apparently healthy, no severe B12 deficiency
Exclusion Criteria:
- pregnancy, lactation, anemia and disease states
Sites / Locations
- Universidad Autonoma de Queretaro
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
Vitamin B12
Arm Description
Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.
Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study
Outcomes
Primary Outcome Measures
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
Secondary Outcome Measures
DNA methylation change, and hematological response to B12 supplementation
Full Information
NCT ID
NCT00826657
First Posted
January 16, 2009
Last Updated
May 19, 2015
Sponsor
USDA, Western Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00826657
Brief Title
Vitamin B12 Supplementation Study
Official Title
Assessment of Functional Vitamin B12 Deficiency in Mexican Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency
Keywords
B12 deficiency, methylmalonic acid, homocystein, vitamin B12 supplementation intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.
Arm Title
Vitamin B12
Arm Type
Active Comparator
Arm Description
Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B12
Intervention Description
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
Primary Outcome Measure Information:
Title
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
Time Frame
0 and 3 mos
Secondary Outcome Measure Information:
Title
DNA methylation change, and hematological response to B12 supplementation
Time Frame
0 and 3 mos
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women age 20-59, apparently healthy, no severe B12 deficiency
Exclusion Criteria:
pregnancy, lactation, anemia and disease states
Facility Information:
Facility Name
Universidad Autonoma de Queretaro
City
Queretaro
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
22915298
Citation
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.
Results Reference
derived
Learn more about this trial
Vitamin B12 Supplementation Study
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