None listed
Conditions
Brief summary
The primary purpose of this study is to increase vitamin B12 stores in South Asian women of child bearing age. The hypothesis is that individualized dietary advice to increase intake of vitamin B12 containing foods will be more effective over 6 months than low dose (6mcg) B12 supplementation which in turn will be more effective than placebo in increasing serum vitamin B12 levels. Blood samples will be taken to monitor serum B12, folate, Active B12 ( HoloTC) , glucose, insulin, lipids, and full blood count at entry into the study, 6 weeks and 6 months post enrolment
Interventions
A vitamin B12 supplement capsule for oral supplementation. The capsule contains cyanocobalamin 6mcg [Vitamin B12 0.1% water soluble] and microcrystalline cellulose as the filler filled into a vegetable Capsugel. Participants in the vitamin B12 supplement group are to take one capsule daily (by oral ingestion) continuously for a period of six months. Repeat bottles of vitamin B12 supplement capsules will be hand delivered to participants at six weeks, and three months and four and a half months
A vitamin B12 supplement capsule for oral supplementation. The capsule contains cyanocobalamin 6mcg [Vitamin B12 0.1% water soluble] and microcrystalline cellulose as the filler filled into a vegetable Capsugel. Participants in the vitamin B12 supplement group are to take one capsule daily (by oral ingestion) continuously for a period of six months. Repeat bottles of vitamin B12 supplement capsules will be hand delivered to participants at six weeks, and three months and four and a half months post enrolment into the study. Any remaining supplement capsules from the previous period will be manually counted to measure compliance with capsule intake. At the completion of the six month study period the vitamin B12 supplementation group will be offered individualized dietary advice to increase or maintain their intake of vitamin B12 containing foods to a minimum intake of 2.4 mcg of vitamin B12 per day. This advice will be given once only at the six month (and final) measurement visit.
Sponsors
Faculty of Health & Environmental Sciences, AUT University.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Apparently healthy South Asian women who live in the Blockhouse Bay, Sandringham, Mt Roskill, Balmoral, Onehunga, Mt Albert & St Lukes areas of Auckland.
Exclusion criteria
Pregnancy or breast feeding, any major health conditions, any known gastrointestinal malabsorption problems, on medication that may interfere with vitamin B12 absorption (metformin, proton pump inhibitors), neocytamin supplementation within the last 12 months.
Outcome results
None listed