Contact information
Type
Scientific
Primary contact
Dr Chittaranjan Yajnik
ORCID ID
Contact details
Diabetes Unit
6th Floor
King Edward Memorial Hospital and Research Centre
Rasta Peth
Pune
411011
India
+91 (0)20 2611 1958
diabetes@vsnl.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
079877/Z/06/Z
Study information
Scientific title
Acronym
Study hypothesis
Primary hypothesis:
To test the hypothesis (H0) that, in children and their parents from the Pune Maternal Nutrition Study (PMNS), daily supplementation with either 2 µg or 10 µg of vitamin B12, with or without folic acid (at 4 months and 1 year), has no effect on serum levels of vitamin B12, total Homocysteine (tHcy), folate and Methylmalonic Acid (MMA).
Secondary hypotheses:
1. To test the hypothesis that in children from the PMNS, daily supplementation with either 2 µg or 10 µg of vitamin B12, with or without folic acid, for 12 months has no effect on body composition, insulin resistance (Homeostasis Model Assessment [HOMA]) or neuro-cognitive performance
2. To test the hypothesis that in the parents from the PMNS, daily supplementation with either 2 µg or 10 µg of vitamin B12, with or without folic acid, for 12 months has no effect on body composition and insulin resistance
Ethics approval
Approval received from the King Edward Memorial Hospital And Research Centre Ethics Committee on the 11th April 2006 (ref: KEMHRC/VSP/Dir Off/EC/065; Project No. 067).
Study design
Single-centre, interventional, randomised, double blind, 2 x 3 factorial study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Micronutrient deficiency in Developmental Origins of Health and Disease (DOHaD)
Intervention
Each participant will be given one of the following six medications, to be taken orally, one capsule per day for a period of 12 months:
1. Folic acid, 0 µg and vitamin B12, 0 µg (placebo)
2. Folic acid, 0 µg and vitamin B12, 2 µg
3. Folic acid, 0 µg and vitamin B12, 10 µg
4. Folic acid, 200 µg and vitamin B12, 0 µg
5. Folic acid, 200 µg and vitamin B12, 2 µg
6. Folic acid, 200 µg and vitamin B12, 10 µg
Secondary sponsor for this trial:
MRC, Epidemiology Resource Centre
Southampton General Hospital
Southampton, S016 6YD
United Kingdom
Tel: +44 (0)2380 777624
http://www.mrc.soton.ac.uk
Intervention type
Supplement
Phase
Not Specified
Drug names
B12 and folic acid supplementation
Primary outcome measures
Serum levels of vitamin B12, folate, tHcy, and MMA, measured at the end of four months and twelve months of supplementation.
Secondary outcome measures
1. Haemogram
2. Blood glucose
3. Lipid profile
4. Serum creatinine
5. Insulin levels
6. Body composition (anthropometry, Dual Energy X-ray Absorptiometry [DEXA])*
7. Blood pressure
8. Grip-strength*
9. Neuro-cognitive performance*
10. Arterial elasticity*
11. Food Frequency Questionnaire (FFQ)*
(* These will be measured only in children). All secondary outcomes to be measured at the end of 12 months of supplementation.
Overall trial start date
01/04/2007
Overall trial end date
31/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Parents and children belonging to a subset of the Pune Maternal Nutrition Study cohort consenting for participation.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
110 families (330 individuals)
Participant exclusion criteria
1. Refusal to participate
2. Not available to complete the study for 12 months
3. Haemoglobin below lower limit of normal for sex and age, requiring treatment with iron and folic acid, vitamin B12, or both
4. Need to take drugs known to impair the absorption or utilisation of folic acid and vitamin B12, e.g., some antiepileptics
5. Women of child bearing age will be excluded if becoming pregnant
6. Individuals who are taking folic acid and/or vitamin B12 supplements since ten or more days
Recruitment start date
01/04/2007
Recruitment end date
31/03/2008
Locations
Countries of recruitment
India
Trial participating centre
Diabetes Unit, 6th Floor
Pune
411011
India
Sponsor information
Organisation
King Edward Memorial (KEM) Hospital and Research Centre (India)
Sponsor details
Diabetes Unit
Pune
411011
India
+91 (0)20 2611 1958
diabetes@vsnl.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (ref: 079877)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary