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Effect of oral high dose Vitamin B12 on pregnancy outcomes

A Randomized double blind placebo controlled trial to investigate the effect of preconceptional Vitamin B12 supplementation on the pregnancy outcomes in Haroli block in Himachal Pradesh

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005787
Enrollment
2000
Registered
2015-05-20
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: Oral Vitamin B12 tablets 1000 microgram each: commercially available over the counter Vitamin B12 tablets marketed as food supplements and available all over the world as food supplemen

Sponsors

ICMR DHR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Only the married, non-pregnant females who are planning a pregnancy and willing to take drugs as required in the intervention arm or control arm for treatment of anemia will be recruited.

Exclusion criteria

Exclusion criteria: Those reproductive age group females, who are using any mode of contraception, or in lactational amenorrhea, or are diagnosed as infertile, will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The outcome measure will be Adverse Pregnancy Outcomes which will include any one of the following: Adverse Events (AE) o Infertility o Preterm delivery o Intrauterine growth retardation o Intrauterine growth retardation o Neonatal complications requiring admission in hospital o Abortion or threatened abortion requiring treatment o Hyperemesis gravidarum requiring treatment o Gestational Diabetes o Gestational HTN/Preeclampsia/ecclampsia/HELLP syndrome diagnosed by an obstetrician Timepoint: Each trimester of pregnancy At termination of pregnancy 1 month after delivery

Secondary

MeasureTime frame
noneTimepoint: none

Countries

India

Contacts

Public ContactDr Vivek Chauhan

Dr. Rajendra Prasad Government Medical College Tanda, Kangra, HP

drvivekshimla@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026