Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/09/2012
Date assigned
01/11/2012
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chittaranjan Yajnik

ORCID ID

Contact details

Director
Diabetes Unit
6th floor
Banoo Coyaji Building
King Edward Memorial Hospital And Research Centre
Sardar Moodliar Road
Rasta Peth
Pune
411011
India
+91 (0)20 2611 1958
diabetes@vsnl.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Maternal vitamin B12, folate and homocysteine as determinants of inter-generational programming of diabesity: the Pune Intervention 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

Ethics Committee King Edward Memorial Hospital Research Centre, Pune, 17/01/2012, ref: KEMHRC/VSP/Dir. Off/EC/ 2465

Study design

Randomised double-blind placebo-controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

Umbilical cord blood measurement of vitamin B12 concentration

Secondary outcome measures

Birth weight and neonatal body composition (by anthropometric measurements)

Overall trial start date

09/02/2012

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 600

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

Trial participating centre

King Edward Memorial Hospital And Research Centre
Pune
411011
India

Sponsor information

Organisation

King Edward Memorial Hospital Research Centre (India)

Sponsor details

Sardar Moodliar Road
Rasta Peth
Pune
411011
India
+91 (0)20 6603 7336
kemvnr@eth.net

Sponsor type

Hospital/treatment centre

Website

http://www.kemdiabetes.org/

Funders

Funder type

Research council

Funder name

Indian Council of Medical Research (India) ref: 58/1/8/MRC-ICMR/2009/NCD-II

Alternative name(s)

ICMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

India

Funder name

Medical Research Council (MRC) (UK) ref: MR/J000094/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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