Can developmental programming of adiposity and insulin resistance in rural Indian children be reversed during adolescent growth by vitamin B12 supplementation? A pilot study
| ISRCTN | ISRCTN59289820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59289820 |
| Secondary identifying numbers | 079877/Z/06/Z |
- Submission date
- 04/09/2007
- Registration date
- 07/09/2007
- Last edited
- 15/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chittaranjan Yajnik
Scientific
Scientific
Diabetes Unit, 6th Floor
King Edward Memorial Hospital and Research Centre
Rasta Peth
Pune
411011
India
| Phone | +91 (0)20 2611 1958 |
|---|---|
| diabetes@vsnl.com |
Study information
| Study design | Single-centre, interventional, randomised, double blind, 2 x 3 factorial study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 110 families (330 individuals) |
| Key inclusion criteria | Parents and children belonging to a subset of the Pune Maternal Nutrition Study cohort consenting for participation. |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- India
Study participating centre
Diabetes Unit, 6th Floor
Pune
411011
India
411011
India
Sponsor information
King Edward Memorial (KEM) Hospital and Research Centre (India)
Hospital/treatment centre
Hospital/treatment centre
Diabetes Unit
Pune
411011
India
| Phone | +91 (0)20 2611 1958 |
|---|---|
| diabetes@vsnl.com | |
| Website | http://www.kemdiabetes.com |
"ROR" |
https://ror.org/03vcw1x21 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (ref: 079877)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
