Vitamin D DeficiencyNCT01229189
Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.
A study testing Vitamin D in people with Vitamin D Deficiency and Pre Eclampsia, run by Aga Khan University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Vitamin D Deficiency, Pre Eclampsia, Stillbirths
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.
Who cannot join
- Pregnant women with pre existing type 1 or type II diabetes
- Women with multiple fetuses, babies (twins, triplets)
- Pregnant women with high level of Vitamin D
- Babies with multiple congenital anomalies
- Babies with serious birth injury, birth asphyxia and serious infections
- Low birth weight less than 1.5
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Project Office Aga Khan University
Pind Dadan Khan, Punjab Province, 49040
About this study
Official title: Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
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.
Read the detailed description
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.
- Conditions
- Vitamin D Deficiency, Pre Eclampsia, Stillbirths, Low Birth Weight, Prematurity
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Effectiveness, Pregnant women and their neonates
- Medical subject headings
- Vitamin D Deficiency, Pre-Eclampsia, Stillbirth, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
PlaceboDietary supplement
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Maternal and Neonatal Intervention Arm | Experimental | 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. Receives: Dietary Supplement: Vitamin D |
| Maternal and Neonatal Control Arm | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and Neonatal complications
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
Measured: six months post enrolement
Secondary outcomes (1)
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency
Measured: Six months post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc.
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, FRCPCH, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229189
- Sponsor's protocol ID
- Vitamin D Study
- Status last verified
- Mar 2012
- First submitted
- 26 Oct 2010
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
- ClinicalTrials.gov ID
- NCT01229189
- Acronym / sponsor ID
- Vitamin D Study
- Conditions
- Vitamin D Deficiency, Pre Eclampsia, Stillbirths, Low Birth Weight, Prematurity
- Keywords
- Vitamin D, Effectiveness, Pregnant women and their neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- John Snow, Inc.
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal and Neonatal Intervention Arm | Experimental | Dietary Supplement: Vitamin DPregnant 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. |
| Maternal and Neonatal Control Arm | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.
Key exclusion criteria (7 listed)
- Pregnant women with pre existing type 1 or type II diabetes
- Women with multiple fetuses, babies (twins, triplets)
- Pregnant women with high level of Vitamin D
- Babies with multiple congenital anomalies
- Babies with serious birth injury, birth asphyxia and serious infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DMaternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks | Dietary supplement | Maternal and Neonatal Intervention Arm |
| PlaceboPlacebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group. | Dietary supplement | Maternal and Neonatal Control Arm |
Primary outcome
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
1 secondary outcome
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency
Time frame: Six months post recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Official Website of the Aga Khan UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar A Bhutta, FRCPCH, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency and Pre Eclampsia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and Neonatal complications (time frame: six months post enrolement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01229189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.