Improving vitamin B12 status of Indians.

Enhancing cobalamin (vitamin B12) bioavailability in culturally appropriate foods in India

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/021001

Enrollment

600

Registered

2019-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vitamin B12 from novel algal or plant source: Vitamin B12 nutrient bars manufactured from potential algae and plants for upto 120 days. Control Intervention1: Vitamin B12 from conventio

Eligibility

Inclusion criteria

Inclusion criteria: Apparently healthy consenting volunteers

Exclusion criteria

Exclusion criteria: 1. subjects with medical illnesses which will interfere with B12 absorption, metabolism and participation in the trial. 2. subjects with symptomatic B12 deficiency (haemoglobin less than 10 g%, clinical neuropathy), and/or plasma vitamin B12 concentrations less than 100 pM 3. subjects on vitamin B12 supplements or drugs which interfere with absorption (PPI, Metformin etc) 4. Pregnant women or those planning pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma B12 levelTimepoint: 60 days	—

Secondary

Measure	Time frame
Homocysteine levels, holo-transcobalamine, MCV and methy-malonic acid Cultural acceptability Quality of life questionnairesTimepoint: 60 days	—

Countries

India

Contacts

Public ContactDr Chittaranjan Yajnik

Diabetes Unit, KEM Hospital Research Centre.

csyajnik@gmail.com9822847481

Outcome results