Vitamin B12 Supplementation Study

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Vitamin B12 Deficiency

Treatments: Dietary Supplement: placebo; Dietary Supplement: Vitamin B12

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00826657

200412519-3

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy, lactation, anemia and disease states

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.

Treatment:

Dietary Supplement: placebo

Vitamin B12

Active Comparator group

Description:

Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study

Treatment:

Dietary Supplement: Vitamin B12