Supplementation of vitamin B12 in young men and women, pre-conception, improves the B12 status of their newborns
| ISRCTN | ISRCTN32921044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32921044 |
| ClinicalTrials.gov number | NCT03088189 |
| Secondary identifying numbers | CTRI 2012/12/003212 |
- Submission date
- 14/09/2012
- Registration date
- 01/11/2012
- Last edited
- 21/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Research has suggested that the growth and development of the baby in the womb is an important factor in determining future health and risk of disease. This idea is called fetal programming. The mother’s nutritional status has a major role to play in this programming. Our previous study demonstrated that maternal nutrition is important for the baby’s growth, and micronutrients (vitamins and minerals) seem to be more important than macronutrients (calories, fat and protein). Vitamin B12 deficiency in pregnancy is common in Indian women, is caused mainly by low dietary intake of vitamin B12, and can be corrected using small daily doses of vitamin B12 capsules. The aim of this study is to find out whether B12 supplementation of young women and men improves the vitamin B12 status, birth weight, body composition, and diabetes risk of their children.
Who can participate?
All adolescents aged 16-18 years who took part in the Pune Maternal Nutrition Study.
What does the study involve?
The participants are randomly allocated to receive a daily dose of either vitamin B12 capsules, capsules containing multiple vitamins including vitamin B12, or placebo (dummy) capsules containing no vitamins. Iron and folic acid tablets are also given to all participants as per the current public health policy of the Indian government. In addition to vitamin treatment the participants are also given milk protein supplements in form of cookies or a drink. The multiple vitamins capsule group receive additional protein compared to the other two groups. The study lasts for three years. Participating girls continue to receive the treatment until their first baby is born, whereas the treatment for the boys is stopped when their wives become pregnant. The children born to these young men and women are studied at birth and later to measure their growth and diabetes risk.
What are the possible benefits and risks of participating?
We do not expect any adverse events due to the supplementation. The safety of the treatment and compliance will be monitored by monthly visits of the field staff, and any adverse events would be investigated by a medical officer.
Where is the study run from?
King Edward Memorial Hospital And Research Centre (India)
When is study starting and how long is it expected to run for?
February 2012 to September 2015.
Who is funding the study?
Indian Council for Medical Research and the Medical Research Council, UK.
Who is the main contact?
Dr CS Yajnik
diabetes@kemdiabetes.org
Contact information
Scientific
Director, Diabetes Unit
6th floor, Banoo Coyaji Building
King Edward Memorial Hospital And Research Centre
Sardar Moodliar Road
Rasta Peth
Pune
411011
India
| Phone | +91 (0)20 2611 1958 |
|---|---|
| diabetes@vsnl.com |
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Maternal vitamin B12, folate and homocysteine as determinants of inter-generational programming of diabesity: the Pune Intervention Study |
| Study acronym | PIS |
| Study hypothesis | Intervention in adolescents to improve their vitamin B12 status would improve vitamin B12 status of the offspring and potentially interrupt the intergenerational transmission of diabetes risk in the next generation. |
| Ethics approval(s) | Ethics Committee King Edward Memorial Hospital Research Centre, Pune, 17/01/2012, ref: KEMHRC/VSP/Dir. Off/EC/ 2465 |
| Condition | Nutrition and developmental origins of health and disease |
| Intervention | The three intervention groups are as follows: 1. Vitamin B12 capsules - 1.0 µg 2. Multiple micronutrients capsules: Vitamin A - 300 µg Vitamin D - 200 IU Vitamin E - 5 mg Vitamin C - 20 mg Vitamin B1 - 0.75 mg Vitamin B2 - 0.9 mg Vitamin B3 - 10 mg Vitamin B6 - 1 mg Vitamin B12 - 1.0 µg Zinc - 6 mg Copper - 1 mg Selenium - 20 µg Iodine - 75 µg 3. Placebo capsules Daily protein supplement (drink or biscuits etc) 1. Minimal milk protein 2. About 5 gm of additional milk protein/day 3. Minimal milk protein Iron (100mg), Folic acid (500mcg) tablets to all 3 groups will be provided as per the Government of India Guidelines. Dose of capsules: 2 capsules per day Duration: 3 years or delivery of the first child, whichever is earlier Duration of follow-up: Until four weeks after delivery of the first child |
| Intervention type | Other |
| Primary outcome measure | Umbilical cord blood measurement of vitamin B12 concentration |
| Secondary outcome measures | Birth weight and neonatal body composition (by anthropometric measurements) |
| Overall study start date | 09/02/2012 |
| Overall study end date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Approximately 600 |
| Total final enrolment | 557 |
| Participant inclusion criteria | 1. Adolescents in the Pune Maternal Nutrition Study (boys and girls) 2. Who are not pregnant 3. Who agree to participate (assent) in the study 4. Whose parent/s give informed written consent |
| Participant exclusion criteria | 1. Plasma vitamin B12 concentration <100pmol/L 2. Haemoglobin concentration <7g/dL 3. Severe developmental disability likely to interfere with marriage and reproduction 4. Serious systemic illness (that would prohibit participation in any clinical trial, e.g. malignancy, reproductive system disorder leading to infertility, congenital or acquired cardiovascular disease with New York Heart Association (NYHA) Functional Classification III or IV) 5. Treatment with drugs interfering with one-carbon metabolism [e.g. folate antagonists: phenytoin, valproic acid, carbamazepine, trimethoprim, methotrexate; B12 antagonists: metformin, Proton-pump inhibitors (PPIs)] 6. Treatment with hematinics (containing B group of vitamins) for more than 30 days |
| Recruitment start date | 09/02/2012 |
| Recruitment end date | 01/07/2012 |
Locations
Countries of recruitment
- India
Study participating centre
411011
India
Sponsor information
Hospital/treatment centre
Sardar Moodliar Road
Rasta Peth
Pune
411011
India
| Phone | +91 (0)20 6603 7336 |
|---|---|
| kemvnr@eth.net | |
| Website | http://www.kemdiabetes.org/ |
"ROR" |
https://ror.org/056yyyw24 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/05/2017 | 15/10/2020 | Yes | No |
| Preprint results | non-peer-reviewed results | 13/09/2021 | 21/09/2021 | No | No |
Editorial Notes
21/09/2021: The following changes have been made:
1. Preprint reference added.
2. The total final enrolment number has been added from the reference.
3. The ClinicalTrials.gov number has been added from the reference.
4. An additional registration number has been added to the protocol /serial number field from the reference.
15/10/2020: Publication reference added.
