Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01229189|
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : March 8, 2012
Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency
The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Pre Eclampsia Stillbirths Low Birth Weight Prematurity||Dietary Supplement: Vitamin D Dietary Supplement: Placebo||Not Applicable|
The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population.
The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Maternal and Neonatal Intervention Arm
Pregnant women will be individually randomized; a daily dose of vitamin D in 4000 IU will be given to Intervention group, started at 20-22 weeks of pregnancy till the time of delivery. The infants of this group will further stratify into two groups, one group will receive 400 IU of Vitamin D for 6 months as Intervention.
Dietary Supplement: Vitamin D
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
|Placebo Comparator: Maternal and Neonatal Control Arm||
Dietary Supplement: Placebo
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
- Maternal and Neonatal complications [ Time Frame: six months post enrolement ]Preeclampsia, hypertension ,poor weight gain etc during pregnancy.Still birth rates, Rate of low birth weight, prematurity,Neonatal seizures, Infants with growth failure, signs and symptoms of vitamin D deficiency. Infants with infections: pneumonia, diarrhea and Receptor polymorphism
- Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency [ Time Frame: Six months post recruitment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229189
|Project Office Aga Khan University|
|Pind Dadan Khan, Punjab, Pakistan, 49040|
|Principal Investigator:||Zulfiqar A Bhutta, FRCPCH, PhD||Aga Khan University|