Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/09/2007
Date assigned
07/09/2007
Last edited
15/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kemdiabetes.com

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

http://www.kemdiabetes.com

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

Publication citations

Additional files

Editorial Notes