Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000262000
Ethics application status
Approved
Date submitted
22/03/2010
Date registered
31/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breaking the cycle: Intergenerational effects from low vitamin B12 in South Asian women
Scientific title
Breaking the cycle of intergenerational effects from low vitamin B12 in South Asian women: a stratified, randomised trial comparing the efficacy and acceptability of vitamin B12 dietary advice, B12 supplement or placebo
Secondary ID [1] 1544 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin B12 deficiency 257000 0
Condition category
Condition code
Diet and Nutrition 257161 257161 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256176 0
Early detection / Screening
Intervention code [2] 256177 0
Prevention
Comparator / control treatment
Comparator 1: Placebo capsule only for 6 months. The placebo is a capsule for oral supplementation that is visually identical to the vitamin B12 supplement capsule. It contains Microcrystalline cellulose as filler and red food colour powder as colour, filled into a vegetable Capsugel. The placebo treatment will be one capsule daily (by oral ingestion) continuously for a period of six months. Repeat bottles of placebo supplement capsules will be hand delivered to participants at six weeks, three months and four and a half months post enrolment into the study. Any remaining placebo supplement capsules from the previous period will be manually counted to measure compliance with the capsule intake. At the completion of the six month study period the vitamin B12 supplementation group will be offered indivdualized dietary advice to increase or maintain their intake of vitamin B12 containing foods to a minimum of 2.4 mcg of vitamin B12 per day. This advice will be given once only at the six month (and final) measurement visit.
Comparator 2: Vitamin B12 dietary advice only at baseline, six weeks, three months and six months. This involves one on one individualized dietary advice to increase or maintain intake of vitamin B12 containing foods. The dietary advice will be administered by the researcher and will be tailored to the participants preferred intake of vitamin B12 containing foods as assessed from one on one interviews with the participant and the researcher administered food frequency questionnaire at baseline, six weeks, three months and six months. The dietary advice will recommend in writing the quantity and type of vitamin B12 containing foods required for a minimum dietary vitamin B12 intake of 2.4 mcg per day, ongoing over the six month study period. In between the data collection periods, the researcher is available to participants by telephone or email if any clarification of the vitamin B12 dietary advice is required.
Control group
Placebo

Outcomes
Primary outcome [1] 258046 0
Primary Outcome 1: Increase in mean serum Vitamin B12 by a mean of 66pmol/L +/- 71. This will be measured by blood analysis for serum B12 levels (using Modular Analytics E170 immunaoassay analyser).
Timepoint [1] 258046 0
Baseline, 6 weeks, 6 months
Primary outcome [2] 258047 0
Increase in mean HoloTC concentration as measured by blood analysis of Active B12 levels (using AxSYM Analyzer)
Timepoint [2] 258047 0
Baseline, 6 weeks, 6 months
Secondary outcome [1] 263625 0
Increase in consumption of vitamin B12 contatining foods (dietary intervention group only) as measured by a researcher administered food frequency questionnaire that focuses on intake of B12 containing foods.
Timepoint [1] 263625 0
Baseline, 6 weeks, 3 & 6 months
Secondary outcome [2] 263680 0
Adherence with placebo or B12 supplement capsules over a 6 month period as measured by remaining capsule counts in bottles when B12 or placebo supplement bottles exchanged at 6 weeks, 3 & 6 months ( B12 supplement and placebo groups only).
Timepoint [2] 263680 0
Baseline, 6 weeks, 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited through advertisment.
Stratified into one of two strata by meat/non-meat eating diet. Participants from each stratum randomly assigned to one of the three intervention groups. A third party not directly involved in the research will be responsible for the randomisation process using a sequence matched random number table. That third party will keep in a locked safe, the confidential record of the participant study ID matched to their sequence number and name. Direct members of the research team will not be aware of who has been assigned to what group or the matching of a name to the study ID.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number tables. As participants volunteer to take part they will be allocated a meat or non meat strata sequence number that corresponds to a number on the table allocating them to one of three groups. The sequence number and its matching to the random number will be known only to the third party not directly associated with the research. Direct members of the research team will not have access to the participant name/ sequence number/random number matching table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
One of the intervention groups is a dietary advice group to compare the efficacy of dietary advice to increase serum B12 with the B12 supplementation and placebo groups. It is not feasible to blind the dietary advice group participants or the research assistant providing dietary advice and collecting the group data. The data from this group will be entered and initially analysed with the researcher unaware of which group the data is from.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 2554 0
New Zealand
State/province [1] 2554 0
Auckland

Funding & Sponsors
Funding source category [1] 256681 0
University
Name [1] 256681 0
AUT University,Faculty of Health & Environmental Sciences Contestable grant
Country [1] 256681 0
New Zealand
Primary sponsor type
University
Name
Faculty of Health & Environmental Sciences, AUT University.
Address
AUT University,
Private Bag 92006, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 255969 0
Government body
Name [1] 255969 0
STAR Project PhD Scholarship
Address [1] 255969 0
STAR Project
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92016
Auckland Mail Centre
Country [1] 255969 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258706 0
AUT University Ethics Committee
Ethics committee address [1] 258706 0
Executive Secretary
AUTEC, AUT University, Private Bag 92006, Auckland
Ethics committee country [1] 258706 0
New Zealand
Date submitted for ethics approval [1] 258706 0
Approval date [1] 258706 0
23/12/2008
Ethics approval number [1] 258706 0
AUTEC 08/02

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30963 0
Address 30963 0
Country 30963 0
Phone 30963 0
Fax 30963 0
Email 30963 0
Contact person for public queries
Name 14210 0
Gael Mearns
Address 14210 0
Faculty of Health and Environmental Sciences, AUT University, Private Bag 92006
Country 14210 0
New Zealand
Phone 14210 0
+64 9 9219999 ext 7108
Fax 14210 0
+64 9 9219796
Email 14210 0
[email protected]
Contact person for scientific queries
Name 5138 0
Professor Elaine Rush
Address 5138 0
Faculty of Health and Environmental Sciences, AUT University, Private Bag 92006
Country 5138 0
New Zealand
Phone 5138 0
+64 9 9219999 ext 8091
Fax 5138 0
+64 9 9219796
Email 5138 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPreventing vitamin B12 deficiency in South Asian women of childbearing age: a randomised controlled trial comparing an oral vitamin B12 supplement with B12 dietary advice2014https://doi.org/10.1038/ejcn.2014.56
N.B. These documents automatically identified may not have been verified by the study sponsor.