Vitamin B12 Supplementation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00826657
First received: January 16, 2009
Last updated: May 19, 2015
Last verified: May 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DNA methylation change, and hematological response to B12 supplementation [ Time Frame: 0 and 3 mos ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 59 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826657

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

No publications provided by USDA, Western Human Nutrition Research Center

Additional 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
Study First Received: January 16, 2009
Last Updated: May 19, 2015
Health Authority: United States: Federal Government

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
Deficiency Diseases
Vitamin B Deficiency
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Avitaminosis
Malnutrition
Nutrition Disorders
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015